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Home > "S" Clinical Trials Conditions > SarCNU in Treating Patients With Recurrent Malignant Glioma  SarCNU in Treating Patients With Recurrent Malignant Glioma
SarCNU in Treating Patients With Recurrent Malignant Glioma
For Condition: adult anaplastic astrocytoma,recurrent adult brain tumor,adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent malignant glioma.
Details: OBJECTIVES: I. Determine the efficacy of SarCNU, in terms of objective response and duration of response, in patients with recurrent malignant gliomas. II. Determine the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the time to progression and survival of patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed malignant glioma - Anaplastic astrocytoma (AA) OR - Glioblastoma multiforme (GBM) Recurrent or progressive disease by contrast-enhanced CT scan or MRI after primary surgery and radiotherapy At least 1 bidimensionally measurable lesion - At least 1 cm by 1 cm on contrast-enhanced CT scan or MRI --Prior/Concurrent Therapy-- Biologic therapy: - At least 6 weeks since prior immunotherapy - No concurrent immunotherapy Chemotherapy: - At least 6 weeks since prior chemotherapy - No more than 1 prior adjuvant chemotherapy regimen for AA - No prior chemotherapy for recurrent disease - No other concurrent chemotherapy Endocrine therapy: Patients must be on a stable dose of steroids for at least 2 weeks prior to study Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No prior radiotherapy for recurrent disease - No concurrent radiotherapy Surgery: - See Disease Characteristics - Prior surgery for recurrent disease (e.g., stereotactic biopsy or partial resection) allowed - At least 4 weeks since prior surgery (except for biopsy) Other: - At least 6 weeks since prior investigational agents - No other concurrent investigational agents - No other concurrent anticancer treatment --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: - Absolute granulocyte count at least 1,500/mm3 - Platelet count at least 120,000/mm3 Hepatic: - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary: - DLCO at least 70% of predicted - FVC at least 70% of predicted Other: - No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix - No ongoing or active uncontrolled infection - No other serious illness or medical condition that would preclude study - No history of significant neurologic or psychiatric disorder that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LawrencePanasci, Study Chair, National Cancer Institute of Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Additional Information:
Study ID Numbers: CDR0000068652; CAN-NCIC-IND142
Study Start Date: August 2001
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036660
Other Recurrent Adult Brain Tumor Studies:
1. Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
2. Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
3. SarCNU in Treating Patients With Recurrent Malignant Glioma
4. High-Dose Methotrexate and Leucovorin Followed By Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
5. Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials
SarCNU in Treating Patients With Recurrent Malignant Glioma
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