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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070187 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving immunotherapy using cyclosporine, interferon gamma, and interleukin-2 after stem cell transplantation may help the transplanted cells make an immune response and kill any remaining cancer cells. It is not yet known whether high-dose chemotherapy followed by autologous stem cell transplantation is more effective with or without immunotherapy.
PURPOSE: This randomized phase II/III trial is studying how well high-dose chemotherapy followed by autologous stem cell transplantation, cyclosporine, interferon gamma, and interleukin-2 works and compares it to high-dose chemotherapy followed by autologous stem cell transplantation only in treating patients with refractory or relapsed Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: aldesleukin Drug: carmustine Drug: cyclosporine Drug: cytarabine Drug: etoposide Drug: filgrastim Drug: melphalan Drug: recombinant interferon gamma Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase II/III Study of Immunomodulation After High Dose Myeloablative Therapy With Autologous Stem Cell Rescue for Refractory/Relapsed Hodgkin Disease |
Study Start Date: | November 2003 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of Hodgkin's lymphoma
No recurrence without B symptoms or bulky disease at least 1 year after completion of minimal systemic therapy defined by either of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Allen R. Chen, MD, PhD, MHS | Sidney Kimmel Comprehensive Cancer Center |
Investigator: | Sharon L. Gardner, MD | New York University School of Medicine |
Study ID Numbers: | CDR0000330135, COG-AHOD0121 |
Study First Received: | October 3, 2003 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00070187 |
Health Authority: | United States: Federal Government |
recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma |
Melphalan Immunoproliferative Disorders Hodgkin's disease Cyclosporine Interferon Type II Clotrimazole Miconazole Hodgkin lymphoma, adult Carmustine Interferons Tioconazole Cyclosporins |
Etoposide phosphate Recurrence Lymphatic Diseases Aldesleukin Interleukin-2 Hodgkin lymphoma, childhood Lymphoproliferative Disorders Etoposide Lymphoma Hodgkin Disease Cytarabine Interferon-gamma, Recombinant |
Antimetabolites Anti-Infective Agents Anti-HIV Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Anti-Retroviral Agents Antifungal Agents Therapeutic Uses Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents |