SarCNU in Treating Patients With Recurrent Malignant Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036660
• Other study ID #: I142
• Secondary ID: CAN-NCIC-IND142C
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2002
• Est. completion date: September 22, 2008

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 22, 2008
• Est. primary completion date: April 15, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioma
• Nervous System Neoplasms

Intervention

Drug:
• SarCNU

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	McGill University	Montreal	Quebec
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation