VNP40101M and Temozolomide in Treating Patients With Progressive or Relapsed Malignant Glioma

PHASE1TerminatedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Brain and Central Nervous System Tumors
Interventions
DRUG

CLORETAZINE

CLORETAZINE will be administered intravenously on day 7. The starting dose of CLORETAZINE will be 100 mg/m2 given within 3 hours after the last dose of Temodar on day 7. CLORETAZINE will be given as an IV infusion over 15-30 minutes via a freely flowing peripheral or central intravenous line. CLORETAZINE will be escalated by 50 mg/m2 for the second cohort then by 25 mg/m2 increments in the following cohorts of 3-6 patients using a standard phase I trial design until a MTD is determined. If dose level 2 has two DLTs then patients will be accrued to a new dose level of 125 mg/m2. Prior to receiving Cloretazine, blood will be drawn for gene methylation studies.

DRUG

temozolomide

Temozolomide will be given orally at a dose of 75mg/m2 daily on day 1 through 7. There will be no dose modification for this agent. Prior to receiving Temozolomide, blood will be drawn for gene methylation studies.

Trial Locations (2)

60611-2998

Hematology-Oncology Associates of Illinois, Chicago

60611-3013

Northwestern University, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Vion Pharmaceuticals

INDUSTRY

lead

Northwestern University

OTHER

NCT00516282 - VNP40101M and Temozolomide in Treating Patients With Progressive or Relapsed Malignant Glioma | Biotech Hunter | Biotech Hunter