SarCNU in Treating Patients With Recurrent Malignant Glioma

NCT ID: NCT00036660

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-10
• Study Completion Date: 2008-09-22

Brief Summary

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.

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

SarCNU

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence C. Panasci, MD

Role: STUDY_CHAIR

Jewish General Hospital

Locations

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

Countries

Canada

References

Webster M, Cairncross G, Gertler S, Perry J, Wainman N, Eisenhauer E. Phase II trial of SarCNU in malignant glioma: unexpected pulmonary toxicity with a novel nitrosourea: a phase II trial of the national cancer institute of canada clinical trials group. Invest New Drugs. 2005 Dec;23(6):591-6. doi: 10.1007/s10637-005-1761-3.

Reference Type: RESULT

PMID: 16034522 (View on PubMed)

Other Identifiers

CAN-NCIC-IND142

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000068652

Identifier Type: OTHER

Identifier Source: secondary_id

I142

Identifier Type: -

Identifier Source: org_study_id