NCT00002941

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin's or Non-Hodgkin's Lymphoma

A Pilot Study of Peripheral Blood Stem Cell Transplantation (PBSCT) After Preparative Therapy Consisting of Cyclophosphamide, BCNU, and Etoposide (CBV) for Recurrent and Primarily Refractory Hodgkin's and Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have recurrent or refractory Hodgkin's lymphoma or non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: * Estimate the failure-free survival rate in a cohort of relapsed Hodgkin's lymphoma and non-Hodgkin's lymphoma patients after retrieval therapy which includes peripheral blood stem cell transplantation (PBSCT) in patients who achieve a complete remission or partial remission. * Estimate the post complete/partial remission failure-free survival rate in these patients. * Characterize the time to recovery of normal bone marrow function after transplantation in these patients. OUTLINE: Patients receive 2 courses of reinduction chemotherapy followed by bone marrow biopsy and aspirate prior to peripheral blood stem cell (PBSC) harvest. If marrow involvement is still present at harvest, then 2 additional courses of induction chemotherapy are given. The PBSC transplantation preparative regimen should begin within 2 weeks of completing reinduction therapy course, consisting of the following: * Carmustine IV over 3 hours on days -8, -7, and -6 * Etoposide continuous IV over days -8, -7, and -6 * Cyclophosphamide IV over 1 hour daily on days -5, -4, -3, and -2 * Mesna as a 15 min infusion before each dose of cyclophosphamide then at 3, 6, 9, and 12 hours after initiation of each cyclophosphamide dose Methylprednisolone IV is given to protect lungs from the toxic effects of carmustine. PROJECTED ACCRUAL: A total of 30 patients will be accrued in each subgroup.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	carmustine
DRUG	cyclophosphamide
DRUG	etoposide
DRUG	mesna
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 1998-04-01
• Primary completion: 2002-11-01
• Completion: 2007-03-01
• First posted: 2003-01-27
• Last updated: 2014-08-01

Locations

235 sites across 7 countries: United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland