|
Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma 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 Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma Clinical research trials and Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma 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 Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma. Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma 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 Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma clinical trial. Participants frequently obtain the most expert healthcare available for their Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma 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 > "I" Clinical Trials Conditions > Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma  Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma
Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma
For Condition: adult glioblastoma multiforme,adult anaplastic oligodendroglioma,adult anaplastic astrocytoma,Mixed Gliomas,recurrent adult brain tumor
Status: Completed
Sponsor(s): Duke Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of irinotecan administered in combination with temozolomide in patients with recurrent primary malignant glioma. - Determine the toxicity of this combination therapy in these patients. OUTLINE: This is a dose escalation study of irinotecan. Patients are stratified according to concurrent anticonvulsants (Dilantin, Tegretol, or phenobarbital vs other anticonvulsants or none). Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and oral temozolomide on days 1-5. Treatment continues every 43 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. PROJECTED ACCRUAL: Not specified
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed recurrent primary malignant glioma - Anaplastic astrocytoma - Glioblastoma multiforme - Anaplastic oligodendroglioma - Gliosarcoma - Anaplastic mixed oligoastrocytoma - Measurable disease by MRI or CT - No immediate radiotherapy required - Neurologically stable for at least 2 weeks prior to study PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Greater than 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT and SGPT less than 2.5 times ULN - Alkaline phosphatase less than 2 times ULN Renal: - Blood urea nitrogen and creatinine less than 1.5 times ULN Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No other nonmalignant systemic disease - No acute infection treated with IV antibiotics - No frequent vomiting or other condition that would preclude oral medication administration (e.g., partial bowel obstruction) - No other prior malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - No more than 1 prior biologic therapy regimen Chemotherapy: - No more than 1 prior chemotherapy regimen - At least 6 weeks since prior chemotherapy, unless evidence of disease progression - No prior failure of irinotecan or temozolomide Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 6 weeks since prior radiotherapy, unless evidence of disease progression Surgery: - At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered Other: - No concurrent immunosuppressive agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryFriedman, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000067931; DUMC-1087-02-6R3,NCI-G00-1795,DUMC-001087-006R1,DUMC-001087-01-6R2,DUMC-1067-99-6
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005951
Other Adult Anaplastic Oligodendroglioma Studies:
1. Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
2. Temozolomide in Treating Patients With Recurrent Malignant Glioma
3. BMS 247550 in Treating Patients With Recurrent Glioma
4. Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
5. Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
Related Studies:
Other adult anaplastic oligodendroglioma Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma
|
|
|
|
|
|
|
|
