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Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical research trials and Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme. Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme clinical trial. Participants typically obtain the most effective healthcare available for their Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme  Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): North American Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
Details: OBJECTIVES: - Determine the efficacy of poly ICLC and radiotherapy, in terms of total survival from date of diagnosis, in patients with newly diagnosed glioblastoma multiforme. - Determine the safety and toxicity profile of this regimen in these patients. - Determine the 12-month survival rate in patients treated with this regimen. - Assess progression-free survival at 6 months and median progression-free survival from date of diagnosis of patients treated with this regimen. - Assess response in patients treated with this regimen. - Assess changes in neurological status in patients treated with this regimen. OUTLINE: This is a multicenter study. Within 1-4 weeks after surgery, patients receive poly ICLC intramuscularly 3 times weekly (on days 1, 3, and 5). Treatment continues in the absence of disease progression or unacceptable toxicity. One week after the initiation of poly ICLC, patients undergo external beam radiotherapy once daily 5 days a week for 6 weeks. Patients are followed monthly for 1 year and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma by biopsy or resection within the past 28 days PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - More than 8 weeks Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic - Bilirubin less than 2 times upper limit of normal (ULN) - SGOT less than 2 times ULN Renal - Creatinine less than 1.5 mg/dL Other - No significant medical illness that cannot be controlled adequately with appropriate therapy or that would compromise tolerability of study therapy - No other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that disease for at least 3 years - No active infection - No disease that would obscure toxicity or dangerously alter drug metabolism - No other serious concurrent medical illness - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior polifeprosan 20 with carmustine implant (Gliadel wafer) - No concurrent chemotherapy Endocrine therapy - Concurrent corticosteroids to treat symptoms or prevent complications are allowed Radiotherapy - No prior radiotherapy to the brain - No concurrent stereotactic radiosurgery - No concurrent brachytherapy Surgery - See Disease Characteristics Other - No prior cytotoxic or noncytotoxic drug therapy for GBM - No prior experimental drug therapy for GBM - No other concurrent cytotoxic or noncytotoxic drug therapy for GBM - Concurrent analgesics, antiepileptics, or other drugs to treat symptoms or prevent complications are allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelPrados, Principal Investigator, University of California, San Francisco
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Susan Chang 415-353-9510
Additional Information:
Study ID Numbers: CDR0000258685; NABTC-0105
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052715
Other Adult Glioblastoma Multiforme Studies:
1. Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
2. Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
3. Sirolimus in Treating Patients With Glioblastoma Multiforme
4. Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma
5. Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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