NCT00098865

Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma

A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with temozolomide may kill more tumor cells. PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide with temozolomide in treating young patients who have relapsed or progressive brain tumors or recurrent neuroblastoma.

Detailed description

OBJECTIVES: Primary * Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas. Secondary * Determine preliminarily evidence of biologic activity of this regimen in these patients. * Determine the toxic effects of this regimen in these patients. STATISTICAL DESIGN: The primary data analysis will estimate the percentage of patients who can complete 6 months of therapy in the mixed population. With a target accrual of 20 patients the 90% confidence for the true feasibility rate will be no wider than 40%.

Conditions

• Central Nervous System Tumor, Pediatric
• Neuroblastoma

Interventions

Type	Name	Description
DRUG	temozolomide	The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.
DRUG	thalidomide	Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose.

Timeline

• Start date: 2002-09-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2004-12-09
• Last updated: 2014-10-07
• Results posted: 2014-09-25

Locations

1 site across 1 country: United States