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Clinical Trials And Noteworthy Treatment For Brain Tumors


Issue #75 5/11/2005

  1. An exciting presentation was made last weekend at a neuro-oncology conference in Europe by Dr Viginia Stark Vance about using the combination of the drugs CPT-11 and AVASTIN. It is too early and too few patients to declare a major breakthrough yet, but it sounds like it is worthy of further study. Note that both components are approved for other cancers, so it is readily available (although very expensive). Here is the abstract:

    Bevacizumab (Avastin®) and CPT-11 (Camptosar®) in the Treatment of Relapsed Malignant Glioma

    Purpose To evaluate the safety and efficacy of Bevacizumab and CPT-11 in the treatment of patients with relapsed malignant glioma

    Patients and Methods As of April 30, 2005, 29 patients with relapsed high grade glioma have received at least four consecutive weeks of treatment with Bevacizumab and CPT-11. Patients received Bevacizumab, 5 mg/kg intravenously over 60-90 minutes, every two weeks. Following bevacizumab, and continuing weekly for four weeks, CPT-11 125 mg/m2 was administered intravenously over 90 minutes. One or two week breaks were allowed at the completion of each treatment cycle. Patients were evaluated by MRI at the initiation of treatment and at the completion of the initial four weeks of therapy. Therapy with Bevacizumab was continued at two-week intervals; CPT-11 was held for Grade 3 myelosuppression or Grade 3 non-hematologic toxicity. Treatment continued until disease progression, intolerable toxicity, or patient’s decision to discontinue treatment.

    Results All patients who completed at least four weeks of treatment were considered evaluable for response and toxicity. Toxicities attributed to Bevacizumab included intracranial hemorrhage (1 pt), bowel perforation (1 pt), wound healing abnormalities (2 pts), and epistaxis (5 pts). Toxicities attributed to CPT-11 included myelosuppression (7 pts), nausea and vomiting (4 pts), diarrhea (17 pts) and other cholinergic symptoms (2 pts). Radiographic evidence of response occurred within the first cycle of treatment, with most responses continuing for the duration of therapy. After the initial four-week treatment cycle, three patients had evidence of disease progression and discontinued therapy. Other responses included 3 CR, 16 PR and 7 SD.

    As of April 30, 11 patients are alive with continuing response to therapy; 2 pts discontinued CPT-11 because of toxicity but continue to respond to other therapy; and 7 patients are alive with evidence of disease progression. Five patients have died of progressive disease; and 4 patients have died of other complications.

    Conclusion Bevacizumab and CPT-11 combination therapy demonstrates rapid clinical and radiographic improvement in patients with relapsed malignant glioma, with some patients achieving long term improvement

    IF anyone tries this.. please enter the virtual trial project first so we can get a good idea of how this is working. (For those who aren’t enrolled yet – this is a study where we just observe what you do. We do not tell you what to do. You just fill out forms on the website and mail us your MRI and pathology reports. No cost to you. For details, go to virtualtrials.com click on virtual trial)

  2. One of our members is having a major fundraiser in Loomis, California, on June 25, 2005. It is called “A Day At The Ranch”, and will have live music, horse exhibitions, face –painting, food fair, the “Hidden Under Our Hats” exhibit, and raffle and auction with many exciting prizes – like a fully restored 1947 Harley Davidson Motorcycle, a horse, and a trip to Hollywood with an invitation to a Hollywood movie premier! For details, go to: http://www.thinkaboutbraintumors.org/

  3. Our inkjet recycling fundraiser is going well. Cartridges are starting to pour in! We have 19 drop off locations in the USA, and growing quickly. Individuals can also collect their own empty inkjet, laser and copier cartridges and request free supplies (boxes, postage-paid return mailing labels) or find a drop off location from our website. Virtualtrials.com/inkjet

  4. If anyone has any interest in running a fundraiser, email or call me to discuss ideas. No experience needed!. We have a few exiting projects waiting for funding! Sincerely,


Al Musella, DPM
President
Musella Foundation
Brain Tumor Research & Information
www.virtualtrials.com
516-295-4740



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