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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002941 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: carmustine Drug: cyclophosphamide Drug: etoposide Drug: mesna Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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 |
Estimated Enrollment: | 30 |
Study Start Date: | June 2002 |
OBJECTIVES:
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:
PROJECTED ACCRUAL: A total of 30 patients will be accrued in each subgroup.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma in first relapse after chemotherapy with more than one nodal region involved at relapse or refractory after primary induction therapy (i.e., failed to achieve remission at the conclusion of standard induction chemotherapy)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Richard E. Harris, MD | Children's Hospital Medical Center, Cincinnati |
Study ID Numbers: | CDR0000065390, COG-A5962, CCG-A5962, POG-A5962, CCG-5962 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002941 |
Health Authority: | United States: Federal Government |
recurrent childhood lymphoblastic lymphoma childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma |
recurrent/refractory childhood Hodgkin lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hodgkin's disease Carmustine Lymphoma, small cleaved-cell, diffuse Cyclophosphamide Lymphoblastic lymphoma Etoposide phosphate Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Recurrence |
Lymphoma, large-cell Lymphatic Diseases Hodgkin lymphoma, childhood Lymphoma, Large-Cell, Immunoblastic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mesna Etoposide Lymphoma Hodgkin Disease |
Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |