- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00036660
SarCNU in Treating Patients With Recurrent Malignant Glioma
A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Alberta
-
Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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-
Ontario
-
Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lawrence C. Panasci, MD, Jewish General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I142
- CAN-NCIC-IND142 (Other Identifier: PDQ)
- CDR0000068652 (Other Identifier: PDQ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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