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SarCNU in Treating Patients With Recurrent Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
SarCNU
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tom Baker Cancer Center - Calgary
  • Ottawa Regional Cancer Centre
  • Toronto Sunnybrook Regional Cancer Centre
  • Toronto General Hospital
  • McGill University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 13, 2002
Last Updated
April 2, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00036660
Brief Title
SarCNU in Treating Patients With Recurrent Malignant Glioma
Official Title
A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2002 (Actual)
Primary Completion Date
April 15, 2003 (Actual)
Study Completion Date
September 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SarCNU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence C. Panasci, MD
Organizational Affiliation
Jewish General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16034522
Citation
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.
Results Reference
result

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SarCNU in Treating Patients With Recurrent Malignant Glioma

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