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Sponsors and Collaborators: |
German Hodgkin's Lymphoma Study Group European Organization for Research and Treatment of Cancer EBMT Solid Tumors Working Party |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025636 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: filgrastim Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: etoposide Drug: melphalan Drug: methotrexate Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Trial Of BEAM Plus PBSCT Versus Single Agent High-Dose Therapy Followed By BEAM Plus PBSCT In Patients With Relapsed Hodgkin's Disease |
Estimated Enrollment: | 220 |
Study Start Date: | July 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, type of relapse (early first relapse [remission duration 3-12 months] vs late first relapse [remission duration more than 12 months] vs second relapse without prior high-dose chemotherapy salvage [remission duration after salvage at least 3 months]), disease status at relapse (stage I or II vs stage III or IV), age (18 to 49 vs 50 to 60), and response after 2 courses of study induction chemotherapy (complete remission vs partial remission vs no change).
All patients receive induction chemotherapy comprising dexamethasone IV over 30 minutes on days 1-4 and 15-18, cisplatin IV continuously over 24 hours on days 1 and 15, cytarabine IV over 3 hours every 12 hours on days 2 and 16, and filgrastim (G-CSF) subcutaneously (SC) once daily on days 5-12 and days 19-26. Patients with complete remission (CR), unconfirmed CR, partial remission, or no change are randomized to one of two treatment arms.
Patients also receive G-CSF SC once on days 38 and 62 and twice daily beginning on day 84 and continuing until blood counts recover. Autologous PBSCs are reinfused on day 85. Patients with residual lymphoma at 100 days after completion of BEAM chemotherapy may receive radiotherapy.
Patients are followed at 100 days after PBSC transplantation, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 220 patients (110 per treatment arm) will be accrued for this study within 5 years.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Early or late first relapse
Second relapse
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Investigator: | Andreas Engert, MD | Medizinische Universitaetsklinik I at the University of Cologne |
Investigator: | J. W. Baars, MD, PhD | Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital |
Investigator: | Norbert Schmitz, MD, PhD | Asklepios Klinik St. Georg |
Study ID Numbers: | CDR0000068981, GHSG-HD-R2, EBMT-GHSG-HD-R2, EORTC-20011 |
Study First Received: | October 11, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00025636 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult Hodgkin lymphoma |
Anti-Inflammatory Agents Dexamethasone Antimetabolites Melphalan Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Cyclophosphamide Hormones Etoposide phosphate Cisplatin Methotrexate Hodgkin Disease Lymphoma |
Etoposide Alkylating Agents Dexamethasone acetate Cytarabine Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hodgkin Lymphoma, Adult Carmustine Hodgkin's Disease Vincristine Antimitotic Agents Folic Acid Antagonists Glucocorticoids Antiviral Agents Immunosuppressive Agents |
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Abortifacient Agents Methotrexate Hodgkin Disease Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Carmustine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Neoplasms Antineoplastic Agents, Phytogenic Antimetabolites Immunologic Factors Antineoplastic Agents Cyclophosphamide Reproductive Control Agents Alkylating Agents |