SarCNU in Treating Patients With Recurrent Malignant Glioma

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00036660

Collaborator

(none)

Enrollment

Locations

80.4

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: SarCNU	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma

Actual Study Start Date :

Jan 10, 2002

Actual Primary Completion Date :

Apr 15, 2003

Actual Study Completion Date :

Sep 22, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2
2	Ottawa Regional Cancer Centre	Ottawa	Ontario	Canada	K1H 1C4
3	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
4	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
5	McGill University	Montreal	Quebec	Canada	H2W 1S6