|
Sirolimus in Treating Patients With Glioblastoma Multiforme Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Sirolimus in Treating Patients With Glioblastoma Multiforme conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Sirolimus in Treating Patients With Glioblastoma Multiforme Clinical research trials and Sirolimus in Treating Patients With Glioblastoma Multiforme medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Sirolimus in Treating Patients With Glioblastoma Multiforme. Sirolimus in Treating Patients With Glioblastoma Multiforme Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Sirolimus in Treating Patients With Glioblastoma Multiforme clinical trial. Participants frequently obtain the most expert healthcare available for their Sirolimus in Treating Patients With Glioblastoma Multiforme condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Sirolimus in Treating Patients With Glioblastoma Multiforme  Sirolimus in Treating Patients With Glioblastoma Multiforme
Sirolimus in Treating Patients With Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme,recurrent adult brain tumor
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemotherapy drugs such as sirolimus use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase I/II trial to study the effectiveness of sirolimus in treating patients who have glioblastoma multiforme that did not respond to previous radiation therapy.
Details: OBJECTIVES: - Determine the maximum tolerated dose of sirolimus in patients with glioblastoma multiforme. - Determine the safety profile of this drug in these patients. - Determine the efficacy of this drug, in terms of 6-month progression-free survival and objective response, in these patients. OUTLINE: This is a dose-escalation study. - Patients receive oral sirolimus for 5-7 days before surgery. Patients then undergo surgical resection. Patients resume oral sirolimus once daily after full recovery from surgery. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive oral sirolimus as in phase I at the dose determined in that phase. Patients are followed for survival. PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for phase I of the study within 3-12 months. A total of 32 patients will be accrued for phase II of the study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed intracranial glioblastoma multiforme - Disease progression by MRI or CT scan - Confirmation of true progressive disease (not radiation necrosis) by positron-emission tomography, thallium scanning, MRI, or surgical documentation required if patient received prior interstitial brachytherapy or stereotactic radiosurgery - Failed prior radiotherapy - Phase I patients: - Eligible for salvage surgery - No limits on prior therapy - Phase II patients: - Tumor progression by MRI or CT scan required within the past 14 days if recurrent disease is present - No prior therapy for more than 3 relapses - Recent resection of recurrent or progressive tumor allowed as long as all of the following conditions apply: - Recovered from surgery - MRI or CT scan performed no more than 96 hours since prior surgery OR within 4-6 weeks after surgery - Baseline MRI or CT scan performed within 14 days of study entry 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 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT less than 1.5 times ULN Renal - Creatinine less than 1.5 mg/dL Other - Cholesterol less than 350 mg/dL - Triglycerides less than 400 mg/dL - No concurrent disease that would obscure toxicity or dangerously alter drug metabolism - No other significant uncontrolled serious medical illness that would preclude study participation - No other cancer except non-melanoma skin cancer or carcinoma in situ of the cervix unless patient is in complete remission and off all therapy for that disease for at least 3 years - No active infection - No prior allergic reactions to compounds of similar chemical or biological composition to sirolimus - No psychiatric illness that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 1 week since prior interferon Chemotherapy - At least 2 weeks since prior vincristine - At least 3 weeks since prior procarbazine - At least 6 weeks since prior nitrosoureas Endocrine therapy - At least 1 week since prior tamoxifen Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy Surgery - See Disease Characteristics Other - Recovered from prior therapy - At least 1 week since prior noncytotoxic agents (except radiosensitizers)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyCloughesy, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Timothy Cloughesy 310-825-5321
Additional Information:
Study ID Numbers: CDR0000257255; UCLA-0203078,NCI-G02-2114
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047073
Other Adult Glioblastoma Multiforme Studies:
1. Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma
2. Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy
3. Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
4. O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
5. Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Sirolimus in Treating Patients With Glioblastoma Multiforme
|
|
|
|
|
|
|
|
