Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 1999 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Emory University
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004688
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: March 1999

February 24, 2000
June 23, 2005
August 1996
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00004688 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms
Not Provided

OBJECTIVES:

I. Assess the clinical response of patients with refractory or recurrent brain neoplasms treated with carmustine, streptozocin, and mercaptopurine.

PROTOCOL OUTLINE:

Patients receive mercaptopurine IV on days 1-3, carmustine by continuous infusion on days 3-5, and streptozocin IV over 20 minutes on days 2-5. Patients receive treatment every 42 days, for up to 4 courses.

Interventional
Phase 2
Primary Purpose: Treatment
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Mixed Gliomas
  • Glioblastoma Multiforme
  • Recurrent Brain Tumor
  • Drug: carmustine
  • Drug: mercaptopurine
  • Drug: streptozocin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
Not Provided
Not Provided

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically proven refractory or recurrent brain neoplasms Glioblastoma multiforme Anaplastic astrocytoma Gliosarcoma Anaplastic oligodendroglioma Mixed anaplastic glioma Unequivocally progressive primary brainstem tumors following primary therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy At least 6 weeks since prior nitrosoureas or mitomycin Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed --Patient Characteristics-- Age: Not specified Performance status: ECOG 0-2 Karnofsky 60-100% Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 4 times normal Renal: Creatinine no greater than 2.0 mg/dL Pulmonary: FEV1 greater than 1 L if symptomatic pulmonary disease present Other: No other concurrent malignancies Not pregnant or lactating Negative pregnancy test Fertile patients must use effective contraception

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00004688
199/13310, EUSM-FDR001274
Not Provided
Not Provided
FDA Office of Orphan Products Development
Emory University
Study Chair: Mark R. Gilbert Emory University
FDA Office of Orphan Products Development
March 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP