Archive for the 'Trials' Category

Children’s Brain Treatment Boosted

Tuesday, February 26th, 2008

URL: http://staffnurse.com/nursing-news-articles/children-s-brain…

Stepping up treatment for children with a deadly brain cancer can dramatically improve survival, British researchers reported today.

During the research on the treatment of children with neuroblastoma, doctors halved the period between treatment with chemotherapy.

Conventionally it was 21 days but the study, reported today by Lancet Oncology, cut this to ten days.

They also increased dose levels by 80 per cent.

After five years, nearly a third of the children on the new treatment programme - some 30.2 per cent - were still alive compared with 18.2 per cent of those on standard treatment.

Some 262 children in six countries took part in the research.

About 90 children a year in Britain are diagnosed with neuroblastoma and the study concentrated on those with the highest risk form of the disease.

Researcher Professor Andy Pearson, of the Royal Marsden Hospital in Sutton, London, said: “Our method of chemotherapy increases the survival rates for children with high risk
neuroblastoma and is already saving the lives of many children.

“Using a higher dose and having chemotherapy with shorter breaks between each treatment means that fewer children will die from the disease each year.”

Kate Law, director of clinical trials at Cancer Research UK, said: “On the strength of the results of this trial, all children in Europe will receive a more effective treatment for this disease.

“Overall survival rates for children’s cancers have been rapidly improving, but it’s crucial we support trials like this that tackle the challenge of advanced cancer.”

More information:

YM Biosciences USA enrolls first patient of phase II trial of Nimotuzumab in children with inoperable, recurrent brain cancer

Wednesday, February 13th, 2008

URL: http://ymbiosciences.com/presspop.cfm?newsID=5492

For more information about the trial, see:
http://clinicaltrials.gov/ct2/show/NCT00600054

MISSISSAUGA, Canada – February 13, 2008 – YM BioSciences Inc. (AMEX: YMI, TSX: YM, AIM: YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that its wholly-owned US subsidiary, YM BioSciences USA Inc. (“YM-USA”) has enrolled the first patient in its Phase II trial investigating nimotuzumab in pediatric patients with recurrent diffuse intrinsic pontine glioma (DIPG), a form of inoperable, treatment-resistant brain cancer. The patient was treated at the M.D Anderson Cancer Center under the care of Dr. Johannes Wolff. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR).

“We are very pleased that this trial is underway in the expectation that nimotuzumab will benefit the children suffering from this insidious form of brain cancer for which there are currently no effective treatments,” said David Allan, Chairman and CEO of YM BioSciences. “If nimotuzumab continues to perform as it has in previous trials, it has the potential to improve clinical outcomes and, particularly, without inflicting the serious side effects that have been reported for the other drugs in its class.”

Eight leading US pediatric clinical centers and two Canadian centers will be participating in the single-arm trial, which is designed to enroll 44 patients with DIPG who will be treated with nimotuzumab as monotherapy. The primary endpoint of the current trial is Response Rate, with a target of 15%, and recruitment is expected to be completed within approximately 18 months.

Positive data from a completed Phase II nimotuzumab monotherapy trial in Europe that included pediatric patients with this recurrent form of brain cancer were reported in an oral presentation at ASCO, 2007. In the 21 patients with DIPG, the clinical benefit rate, which included Partial Response and Stable Disease, was 38% after eight weeks of treatment. Of the eight patients who continued on treatment to week 21, three were assessed with a Partial Response and one with Stable Disease. The Company is not aware of any previous clinical trials that reported Objective Responses in recurrent DIPG.

Recruitment in a Phase III trial combining nimotuzumab with radiation for the first-line treatment of children with DIPG, conducted by Oncoscience AG (YM’s European licensee for nimotuzumab) was completed in August 2007. The primary end-point of the Phase III trial is Progression-Free Survival with Overall Survival as a secondary endpoint. YM anticipates that data from this trial will be available mid-2008 and, if positive, are expected to be supportive of an application in 2008 for marketing approval in Europe. An application for marketing authorization of nimotuzumab based on earlier stage data was submitted to EMEA by Oncoscience AG on October 4th, 2007.

Nimotuzumab in combination with radiation-containing regimens has been demonstrated to be effective in other indications for which it is already approved in certain jurisdictions. The clinical benefit of nimotuzumab as monotherapy in a range of patients refractory to all treatments was also published in the proceedings at ASCO, 2007 in addition to the presentation of the pediatric results.

The US investigational trial sites participating in the international Phase II trial include leading pediatric neuro-oncology centers that are members of POETIC (Pediatric Oncology Experimental Therapeutics International Consortium): Vanderbilt Children’s Hospital/Vanderbilt-Ingram Cancer Center; M.D. Anderson Cancer Center; Memorial Sloan-Kettering Cancer Center; the Sidney Kimmel Cancer Center at Johns Hopkins; the Children’s Hospital at the University of Colorado and the University of Florida Children’s Hospital. In addition, the University of Rochester Medical Center and the New York University Medical Center are participating in the trial. In Canada, clinical sites include the Hospital for Sick Children in Toronto, where Drs. Eric Bouffet, Sylvain Baruchel, and Ute Bartels lead the international program, and Alberta’s Children’s Hospital in Calgary.

About Nimotuzumab

Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). To date nimotuzumab has been administered to more than 2000 patients and evaluated in more than a dozen clinical trials. It has been approved in several countries and has been provided on a compassionate basis in a number of countries including the US, Canada, Germany, and Australia. The emerging safety data for nimotuzumab suggests a more benign side-effect profile in its trials with radiation-containing regimens compared to currently approved EGFR targeting antibodies and small molecules. To date, in patients treated with nimotuzumab, there has been no evidence of severe rash or any life-threatening adverse events. The unique safety profile for nimotuzumab holds the prospect for it to become best-in-class within this important family of EGFR-targeting agents.

Nimotuzumab has been designated an Orphan Drug by the US FDA and by the EMEA for glioma.

About YM BioSciences

YM BioSciences Inc. is an oncology company that identifies, develops and commercializes differentiated products for patients worldwide. The Company has two late-stage products: nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is approved in several countries for treatment of various types of head and neck cancer; and AeroLEFÔ, a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.

This press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEFÔ will continue to generate positive efficacy and safety data in future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Combination of implants benefits patients with recurrent glioblastoma

Thursday, February 7th, 2008

Source: Reuters
Author: Will Boggs, MD
Date: Thu, 7 February 2008

URL: http://medicexchange.com/mall/…

The combination of permanent iodine-125 seed implants and carmustine (BCNU) wafers is safe and effective in patients with recurrent glioblastoma multiforme (GBM), according to a report in the February issue of the Journal of Neurosurgery.

“We consider the use of radiation seeds and chemotherapy wafers to be standard treatment for recurrent glioblastoma at our center,” Dr. Ronald E. Warnick from University of Cincinnati, Cincinnati, Ohio told Reuters Health.

Dr. Warnick and colleagues assessed the safety and efficacy of combination adjunctive therapy with permanent, low-activity I-125 seed implants and BCNU wafers following resection in a phase I/II trial involving 34 patients with recurrent GBM.

Median survival after resection and implantation was 69 weeks, the authors report, and survival rates were 82 per cent at six months, 66 per cent at 12 months, 37 per cent at 18 months, and 23 per cent at 24 months.

Tumor recurrence occurred after a median 47 weeks, and the progression-free survival rates were 67 per cent at six months, 32 per cent at 12 months, 20 per cent at 18 months, and 13 per cent at 24 months.

A better Karnofsky performance score was associated with longer survival and progression-free survival, the investigators say, and increased I-125 dose density and lower age were associated with longer overall survival.

Brain necrosis was confirmed by positron electron tomography in eight ptients, the researchers note, but the development of necrosis did not affect survival.

“This treatment can be delivered by any neurosurgeon at nearly any hospital in the world, as opposed to complicated therapies like stem cell therapy, immunotherapy, and vaccines that are limited to just a few of the largest brain tumor centers,” Dr. Warnick commented. “Patients with recurrent glioblastoma do not necessarily need to travel to one of a few major brain tumor centers for their treatment.”

The results of the trial are encouraging enough that the team is moving ahead with other investigational studies, Dr. Warnick added. “We have initiated a clinical trial to test the combination of seeds and wafers in the treatment of newly diagnosed glioblastoma.”

Proton Magnetic Resonance Spectroscopic Imaging in Newly Diagnosed Glioblastoma

Wednesday, February 6th, 2008

Predictive Value for the Site of Postradiotherapy Relapse in a Prospective Longitudinal Study

URL: http://sciencedirect.com/science?_ob=ArticleURL&_udi=B6T7X-4RSFS1Y-C…

Anne Laprie M.D., Ph.D*, †, , ,
Isabelle Catalaa M.D., Ph.D†, §,
Emmanuelle Cassol Ph.D.†,
Tracy R. McKnight Ph.D.¶,
Delphine Berchery M.D.,
Delphine Marre Ph.D.*,
Jean-Marc Bachaud M.D.*,
Isabelle Berry M.D., Ph.D†
Elizabeth Cohen-Jonathan Moyal M.D., Ph.D*, ‡

Department of Medical Information, Institut Claudius Regaud, Toulouse, France
†Laboratory of Biophysics and Medical Imaging, Universite Toulouse III Paul Sabatier, Toulouse, France
‡Department of Therapeutic Innovation and Molecular Oncology, Institut Claudius Regaud, INSERM, U563, Toulouse, France
*Department of Radiation Oncology, Institut Claudius Regaud, Toulouse, France
§Department of Neuroradiology, Hôpital Rangueil, CHU Toulouse, Toulouse, France
¶Center for Molecular and Functional Imaging, University of California–San Francisco, San Francisco, CA

Received 24 August 2007; revised 26 October 2007; accepted 30 October 2007. Available online 6 February 2008.

Purpose

To investigate the association between magnetic resonance spectroscopic imaging (MRSI)–defined, metabolically abnormal tumor regions and subsequent sites of relapse in data from patients treated with radiotherapy (RT) in a prospective clinical trial.

Methods and Materials

Twenty-three examinations were performed prospectively for 9 patients with newly diagnosed glioblastoma multiforme studied in a Phase I trial combining Tipifarnib and RT. The patients underwent magnetic resonance imaging (MRI) and MRSI before treatment and every 2 months until relapse. The MRSI data were categorized by the choline (Cho)/N-acetyl–aspartate (NAA) ratio (CNR) as a measure of spectroscopic abnormality. CNRs corresponding to T1 and T2 MRI for 1,207 voxels were evaluated before RT and at recurrence.

Results

Before treatment, areas of CNR2 (CNR ?2) represented 25% of the contrast-enhancing (T1CE) regions and 10% of abnormal T2 regions outside T1CE (HyperT2). The presence of CNR2 was often an early indicator of the site of relapse after therapy. In fact, 75% of the voxels within the T1CE+CNR2 before therapy continued to exhibit CNR2 at relapse, compared with 22% of the voxels within the T1CE with normal CNR (p < 0.05). The location of new contrast enhancement with CNR2 corresponded in 80% of the initial HyperT2+CNR2 vs. 20.7% of the HyperT2 voxels with normal CNR (p < 0.05).

ConclusionM

Metabolically active regions represented a small percentage of pretreatment MRI abnormalities and were predictive for the site of post-RT relapse. The incorporation of MRSI data in the definition of RT target volumes for selective boosting may be a promising avenue leading to increased local control of glioblastomas.

Clinical Trial Of Brain Cancer Vaccine Begins At New York University’s Department Of Neurology And Neurosurgery

Tuesday, February 5th, 2008

URL: http://medicalnewstoday.com/articles/96213.php
05 Feb 2008

Doctors at New York University Medical Center’s Department of Neurology and Neurosurgery are seeking candidates to participate in Phase II clinical trials of a new cutting-edge personalized brain cancer vaccine.

Dr. Patrick Kelly, the world renowned neurosurgeon who is Professor of Neurosurgery at NYUMC, and Dr. Michael Gruber, the prominent neuro-oncologist who is Clinical Professor at NYUMC, are the first doctors in New York State - and NYUMC is only one of five centers nationwide - to utilize this personalized vaccine. It is created by taking a portion of a patient’s brain tumor and combining it with dendritic white blood cells. Once the vaccine is injected intra-dermally, it creates an immune reaction resulting in the remaining cancer cells being killed. If successful, the patient’s survival rate may increase over 50%.

In fact, in the initial study of this vaccine (conducted at UCLA), two-thirds of the patients were still alive after two years, compared to one-third who only received standard treatment. Moreover, two-fifths of the vaccine-treated patients who survived two years showed no evidence of the disease.

Patients who are candidates for the Phase II trial at NYUMC must be newly-diagnosed, and have not had any other treatment, including chemotherapy and/or radiation. They will first undergo a minimally-invasive procedure to remove the tumor.

There are two main types of brain cancer. Primary brain cancer starts in the brain. Metastatic brain cancer starts somewhere else in the body and moves to the brain. Brain tumors can be benign, with no cancer cells, or malignant, with cancer cells that grow quickly. Brain cancer affects about 29,000 Americans each year. About 13,000 die from a brain tumor a year.

More information:

MGI PHARMA Announces Results from Study Involving the Dual Implantation of Gliadel(R) Wafer and Radioactive Seeds for Treatment of Recurrent Glioblastoma Multiforme

Friday, January 18th, 2008

MGI PHARMA Announces Results from Study Involving the Dual Implantation of Gliadel(R) Wafer and Radioactive Seeds for Treatment of Recurrent Glioblastoma Multiforme

New Data Published in Journal of Neurosurgery Suggest a Novel Treatment Combination of Localized Therapies Shows Promise

URL: http://investors.mgipharma.com/…

MINNEAPOLIS–(BUSINESS WIRE)–Jan. 18, 2008–MGI PHARMA, INC. (NASDAQ:MOGN), a biopharmaceutical company focused in oncology and acute care, today announced that study results published in the February issue of the Journal of Neurosurgery show that treatment of patients who have recurrent glioblastoma multiforme (GBM) with both Gliadel(R) Wafer and radioactive seeds (iodine-125) at the time of tumor resection, may provide for a better outcome than treatment of patients with surgery and either agent alone.

The study was led by Ronald E. Warnick, M.D., Chairman of the Mayfield Clinic and professor of neurosurgery at the University of Cincinnati. This is the first study ever conducted to evaluate the effect of these two novel agents used simultaneously in combination with surgery to treat recurrent GBM. The Phase 1/2 single-arm study explored the safety and efficacy of the localized therapies in 34 patients. The dual implantation of Gliadel Wafer and radioactive seeds was well-tolerated among patients and may contribute to longer survival than when surgery is coupled with either therapy alone. Additional controlled clinical trials will need to be conducted in order to confirm this finding and demonstrate a survival benefit in comparison to control.

“Recurrent glioblastoma is a challenging disease, because the tumor grows and spreads so quickly,” Dr. Warnick said. “These results suggest that by simultaneous application of two localized therapies, Gliadel Wafer and radioactive seeds, we may be able to provide an improved survival benefit for this patient population. We will continue to conduct further studies of this approach for both recurrent and newly diagnosed glioblastoma.”

About Gliadel(R) Wafer

Gliadel(R) (polifeprosan 20 with carmustine implant) Wafer is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. Gliadel is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery. Gliadel should not be given to individuals who have demonstrated a previous hypersensitivity to carmustine or any of the components of Gliadel. Patients undergoing craniotomy for malignant glioma and implantation of Gliadel should be monitored closely for complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema.

Communication between the surgical resection cavity and the ventricular system should be avoided to prevent the wafers from migrating into the ventricular system and causing obstructive hydrocephalus. If a communication larger than the diameter of a wafer exists, it should be closed prior to wafer implantation. Computed tomography and magnetic resonance imaging of the head may demonstrate enhancement in the brain tissue surrounding the resection cavity after implantation of Gliadel. This enhancement may represent edema and inflammation caused by Gliadel or tumor progression. The short-term and long-term toxicity profiles of Gliadel, when given in conjunction with chemotherapy have not been fully explored.

About MGI PHARMA

MGI PHARMA, INC. is a biopharmaceutical company focused in oncology and acute care that acquires, researches, develops, and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) Injection, Dacogen(R) (decitabine) for Injection, and Gliadel(R) Wafer (polifeprosan 20 with carmustine implant) in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.

This news release contains certain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA’s future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause MGI PHARMA’s results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the determinations by FDA regarding the safety or efficacy of Gliadel Injection and other risks and uncertainties detailed from time to time in MGI PHARMA’s filings with the Securities and Exchange Commission including its most recently filed Form 10-K and Form 10-Q. MGI PHARMA undertakes no duty to update any of these forward-looking statements.

CONTACT: MGI PHARMA, INC.
Timothy J. Smith, 952-406-3100

SOURCE: MGI PHARMA, INC.

TransMolecular Receives Orphan Drug Designation for Non-radiolabeled TM601 for the Treatment of Malignant Glioma

Monday, January 7th, 2008

URL: http://reuters.com/article/pressRelease/idUS114585+07-Jan-2008+BW20080107

CAMBRIDGE, Mass.–(Business Wire)–TransMolecular, Inc., a biotechnology company focused on targeted therapies for cancer, today announced that the FDA has granted Orphan Drug Designation for the non-radiolabeled version of its anti-cancer compound TM601, which is currently entering clinical trials for the treatment of malignant glioma. The company had previously received Orphan designation for the radiolabeled version, 131I-TM601, which recently completed patient enrollment in a Phase 2 clinical trial in glioma and a Phase 1 trial in multiple tumor types.

“We are pleased to receive orphan drug status for TM601 in malignant glioma,” stated Michael Egan, President and Chief Executive Officer of TransMolecular. “The TM601 platform has performed very well in recent Phase 1 and 2 clinical trials, showing specific tumor targeting in both primary and metastatic disease of multiple tumor types. This adds to a strong clinical rationale supporting its therapeutic promise, and we look forward to initiating Phase 1 clinical trials with the non-radiolabeled form of this drug candidate in malignant glioma. This designation is part of TransMolecular’s strategy to advance this program so that patients with this poor-prognosis disease may eventually have a new treatment option available to them.”

The FDA grants Orphan Drug Designation to promising products that address rare diseases affecting fewer than 200,000 Americans annually. If non-radiolabeled TM601 receives FDA approval for malignant glioma, this designation will entitle TransMolecular to exclusive marketing rights for the compound for the treatment of malignant glioma for seven years following the NDA approval. Orphan Drug Designation provides financial and regulatory incentives for companies pursuing less common diseases.

About TM601

TM601 is a synthetic version of chlorotoxin, a naturally occurring peptide derived from scorpion venom, which is highly specific in targeting both primary tumors and metastases. TM601 targets and binds to receptors expressed on tumor cells but not on normal, healthy cells. As TM601 binds primarily with the tumor cell receptor sites, it also delivers a targeted dose of radiation, killing the tumor cell without affecting nearby healthy cells. The data obtained from preclinical and clinical data also suggest that native TM601 may affect a tumor’s ability to grow and spread without added radiation, so the therapeutic potential as a non-radiolabeled peptide is also being explored. The Company’s robust development plan for TM601 reflects its broad platform potential for multiple applications in cancer. The FDA has granted it orphan drug status for patients with high-grade and malignant glioma, as well as a Fast Track designation.

About Glioma

In the U.S., an estimated 20,500 new cases of brain and/or nervous system tumors were expected to be diagnosed in 2007. Of primary brain tumors, malignant glioma is the most common tumor type and is the second most common cause of cancer-related mortality in the 15-to-44 age group. In patients with grade III anaplastic glioma, the median survival is three-to-five years; however, median survival in patients with grade IV glioma or glioblastoma multiforme is less than a year.

Despite over twenty-five years of intensive research and a variety of chemotherapy, radiotherapy, and surgical approaches, the prognosis for these tumors has not changed significantly. Primary brain tumors remain one of the most aggressive and difficult-to-treat cancers.

About TransMolecular, Inc.

TransMolecular, Inc. is a privately held, venture capital backed biotechnology company committed to discovering, developing and commercializing novel and proprietary products to diagnose and treat cancers that have inadequate treatment alternatives. TransMolecular’s product pipeline is based on a protein platform that employs a therapeutically active polypeptide derived from scorpion venom. The company is currently exploring the use of this platform for broad applications to diagnose and treat cancers and other human diseases.
More information can be found at www.transmolecular.com.

This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with litigation, clinical trials, the regulatory approval process, reimbursement policies, commercialization of new technologies, intellectual property, and other factors.

TransMolecular
Michael Egan, 617-995-3050
President and CEO
or
Media
MacDougall Biomedical Communications
Jennifer Greenleaf, 781-235-3060

More Information:
TM601-001 – Phase I/II single-dose dose open label study in patients with recurrent glioma

Combination Treatment Reduces Volume of Brain Metastases in Breast Cancer Patients

Monday, December 17th, 2007

URL: http://docguide.com/news/content.nsf/…

SAN ANTONIO, TX — December 17, 2007 — The addition of capecitabine to lapatinib in patients with brain metastases from breast cancer was associated with additional responses in the central nervous system, researchers reported here at the 30th Annual San Antonio Breast Cancer Symposium (SABCS).

“Approximately one third of women with HER2-positive metastatic breast cancer develop central nervous system metastases,” said Nancy Lin, MD, Instructor in Medicine, Dana-Farmer Cancer Institute, Boston, Massachusetts.

“Very few medications have shown activity in the treatment of brain metastases, in particular HER-positive metastatic breast cancer patients and, therefore, these data are quite encouraging,” Dr. Lin said during her poster presentation on December 16.

The study enrolled 51 women who had been treated in a lapatinib monotherapy trial in which they received 750 mg of lapatinib twice a day. In the extension study, the women received 1,250 mg a day of lapatinib plus 2,000 mg/m2 per day of capecitabine for 14 days in a 21-day cycle.

In the original study, 242 patients were enrolled and about 23% of patients achieved a 20% or greater decrease in brain tumor volume.

In the extension study, the median progression-free survival was 15.8 weeks. Dr. Lin said 10 of the women achieved a 50% reduction in the volume of their brain metastases and another 18 of the women experienced at least a 20% reduction in the volume of brain metastases.

“It is conceivable that the central nervous system responses observed in the extension arm were entirely as a result of capecitabine,” Dr. Lin said, “However, it is equally possible that the activity is at least partially a consequence of coadministration-given synergy between HER2-directed therapy and chemotherapy.”

Dr. Lin said that the study warrants prospective studies to evaluate the efficacy of lapatinib in combination with chemotherapy and other targeted agents for the treatment and prevention of central nervous system metastases in patients with HER2-positive metastatic breast cancer.

Funding for this study was provided by GlaxoSmithKline.
[Presentation title: Lapatinib and Capecitabine for the Treatment of Brain Metastases in Patients With HER2+ Breast Cancer an Updated Analysis From EGF105084. Abstract 6076]

Virus Kills Brain Tumor Stem Cells in Mice

Monday, December 3rd, 2007

Application to Be Filed for Clinical Trial

Click here for original article.

Scientists have tailored a virus to target and destroy brain tumor stem cells that are unresponsive to other cancer therapies, according to a report in the Sept. 18 edition of the Journal of the National Cancer Institute.

Significance of results

“We have shown, first in lab experiments using cell tissue, and then in stem cell-derived human brain cancer in mice, that we have a tool that can target and eliminate the cells that drive brain tumors,” says co-senior author Juan Fueyo, M.D., an associate professor in M. D. Anderson’s Department of Neuro-Oncology.

“While an animal model doesn’t fully represent what might happen in humans, the tumors grown by these stem cells closely resemble the tumors we see in our patients, which is an exciting finding in itself.”

Research methods

The scientists developed a virus called Delta-24-RGD, which spreads throughout the tumors and destroys cancer cells without affecting healthy cells.

Since 2004, doctors have known that brain tumors are driven by defective stem cells that duplicate, causing the tumor to grow.

The team extracted these defective stem cell lines, or groups, from four specimens with glioblastoma multiforme. This is one of the most dangerous forms of brain cancer that is unresponsive to many therapies. Delta-24-RGD treated and killed all four of the stem cell lines in cell tissue.

The researchers then put these stem cell samples into the brains of mice and treated some of the mice with Delta-24-RGD.

Primary results

The untreated mice lived for an average of 35.5 days, while the mice treated with Delta-24-RGD lived an average of 66 days.

Scientists also discovered that some of the mice survived the length of the experiment without any neurological side effects, which is rare but encouraging, Fueyo says.

“It’s important in animal models to see improvement in survival in the majority of animals, but to have some be cured and survive a long time without neurological symptoms is very rare,” Fueyo says.

What’s next?

The National Cancer Institute has manufactured a clinical quality version of Delta-24-RGD, and an independent consultant has completed a toxicology assessment.

An Investigational New Drug Application will be filed with the U.S. Food and Drug Administration this month. The application is a mandatory step before a Phase I clinical trial can begin.

– Adapted by Asma Siddiqi from an M. D. Anderson news release

Brain Cancer Patient Benefits From New Treatment

Friday, November 9th, 2007

Highly Experimental Device Has Made Daniel Torres One Of The Longest-Living People With This Form Of Cancer

Reporting Mary Ann Childers CHICAGO (CBS)

URL: http://cbs2chicago.com/health/brain.cancer.treatment.2.564650.html

A stunning new and highly experimental treatment for the most deadly type of brain tumor helped save the life of a 52-year-old man.

As CBS 2 Medical Editor Mary Ann Childers reports, Daniel Torres is one of the longest-living survivors of glioblastoma, the most aggressive and deadly form of brain cancer.

“If you look at someone who had a few weeks of life expectancy who’s here for another year, that’s tremendous,” said UIC neurosurgeon Herbert Engelhard, M.D.

CBS 2 first reported Torres’ story a year ago, when he became the first person in the U.S. to try an experimental treatment. At the time, his doctors held out little hope.

“Before he came into the study he’d failed every possible therapy for this disease,” Engelhard said.

For the past year, Torres has worn a device that secures 36 electrodes to his head. He’s worn it 24 hours a day, except when he showers. It generates low intensity electrical currents that blast cancer cells apart just as they start to divide. Healthy brain cells aren’t affected — just the tumor.

“There’s no doubt in my mind that this treatment slowed it down,” Engelhard said.

It hasn’t been an easy year for Torres, his wife, Sylvia, and their four children. They have made 102 hospital visits for blood tests and MRI checks. Torres uses a walker — not for balance, but to carry a seven-pound battery pack.

The news continues to be good; things are stable. One doctor was very optimistic, telling them: “You were here for Thanksgiving and you are going to be for this Thanksgiving and many, many Thanksgivings more,” Sylvia Torres said.

Engelhard hopes that’s the case, but says there’s no real way to know. He says the treatment is not a cure, but it does appear to buy patients precious time. The study runs one more year, and patients may still enroll. Right now, there are 49 other people in the U.S. wearing the device.

Click here for more information, or contact:

University of Illinois at Chicago (recruiting)
Chicago, IL 60612
Principal Investigator: Herbert Engelhard, MD, Ph.D.
Contact: Karriem Watson
800-597-5970

Northwestern University (recruiting)
Chicago, IL 60611
Principal Investigator: Jeffrey Raizer, MD
Contact: Lilia Gallot
312-695-1363