A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma
| Registry | NCT00036660 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 10 (Actual) |
| Sponsor | NCIC Clinical Trials Group (Network) |
| Conditions | Brain and Central Nervous System Tumors |
| Interventions | SarCNU (Drug) |
| Dates | start 2002-01-10, primary completion 2003-04-15, completion 2008-09-22, first posted 2003-07-08, last updated 2020-04-06 |
| Locations | 5 sites in Canada |
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All trials for Brain and Central Nervous System Tumors All trials of SarCNU
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.
OBJECTIVES:
* Determine the efficacy of SarCNU, in terms of objective response and duration of response, in patients with recurrent malignant gliomas.
* Determine the qualitative and quantitative toxic effects of this drug in these patients.
* Determine the time to progression and survival of patients treated with this drug.
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.
Sex: All, ages: 18 Years to 120 Years
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 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 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
| Facility | City | Country | Status |
|---|---|---|---|
| Tom Baker Cancer Center - Calgary | Calgary, Alberta | Canada | |
| Ottawa Regional Cancer Centre | Ottawa, Ontario | Canada | |
| Toronto Sunnybrook Regional Cancer Centre | Toronto, Ontario | Canada | |
| Toronto General Hospital | Toronto, Ontario | Canada | |
| McGill University | Montreal, Quebec | Canada |