SarCNU in Treating Patients With Recurrent Malignant Glioma

This study has been completed.
Sponsor:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00036660
First received: May 13, 2002
Last updated: November 7, 2010
Last verified: March 2010
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: SarCNU
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Study Start Date: August 2001
Study Completion Date: September 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036660

Locations
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Lawrence C. Panasci, MD Jewish General Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00036660     History of Changes
Other Study ID Numbers: I142, CAN-NCIC-IND142, CDR0000068652
Study First Received: May 13, 2002
Last Updated: November 7, 2010
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms by Site
Neoplasms
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014