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SarCNU in Treating Patients With Recurrent Malignant Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00036660
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 NCIC Clinical Trials Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Lawrence C. Panasci, MD
Principal Investigator Affiliation Jewish General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada

Status

Address

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2

Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada

Status

Address

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4

Toronto, Ontario, Canada

Status

Address

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5

Toronto General Hospital, Toronto, Ontario, Canada

Status

Address

Toronto General Hospital

Toronto, Ontario, M5G 2C4

McGill University, Montreal, Quebec, Canada

Status

Address

McGill University

Montreal, Quebec, H2W 1S6

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