VNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain Tumors
NCT00098761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2011-06-30
Summary
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of VNP40101M in treating young patients with recurrent, progressive, or refractory primary brain tumors.
Conditions
Interventions
- DRUG
-
laromustine
This is a dose escalation study. Participants receive 20, 30, 45, 60, 78, 103, 137, 182, or 242 mg/m2/day intravenously over 30 minutes for 5 consecutive days every 6 weeks up to 48 weeks.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Pediatric Brain Tumor Consortium
lead NETWORK
Principal Investigators
-
Sri Gururangan, MRCP (UK) · Duke University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-02-28
- Primary Completion
- 2006-10-31
- Completion
- 2008-02-29
Countries
- United States
Study Locations
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