SarCNU in Treating Patients With Recurrent Malignant Glioma

NCT00036660 | Completed Phase 2 DMC

• 3 other identifiers: I142CAN-NCIC-IND142CDR0000068652
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

SarCNU DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (5)

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Related 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. Invest New Drugs. 2005 Dec;23(6):591-6. doi: 10.1007/s10637-005-1761-3.

  PMID: 16034522 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Glioblastoma; Astrocytoma; Gliosarcoma

Interventions

2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Lawrence C. Panasci, MD

  Jewish General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2002
• First Posted: July 8, 2003
• Study Start: January 10, 2002
• Primary Completion: April 15, 2003
• Study Completion: September 22, 2008
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)