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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: | NCT00005578 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkin's disease.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Lymphoma |
Biological: bleomycin sulfate Biological: filgrastim Drug: cyclophosphamide Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study |
Study Start Date: | March 1997 |
OBJECTIVES: I. Determine the efficacy of doxorubicin, bleomycin, vincristine, etoposide, prednisone and cyclophosphamide (DBVE-PC) with filgrastim (G-CSF) followed by consolidative radiotherapy in children with advanced stage Hodgkin's disease. II. Tailor therapy based on rapidity of response in order to minimize cumulative drug dosages. III. Compare the efficacy of dexrazoxane in reducing pulmonary and cardiac toxicity of DBVE-based therapy without compromising response.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin and etoposide on days 0 and 1, bleomycin and vincristine on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Patients assigned to arm I receive only these drugs. Patients assigned to arm II receive dexrazoxane on days 0, 1, and 7 in addition to therapy as in arm I. Patients who exhibit a complete remission (CR) or provisional CR then receive radiotherapy to the regional field 5 days a week for 2.8 weeks. If the disease is not responsive, 2 more courses of chemotherapy are given.
Patients whose disease remains nonresponsive or progresses go off the study. Radiotherapy may follow for others. Patients are followed every 3 months for the first year, every 4 months for the second year, every 6 months for the third year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 277 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease of the following stages: Stages IIB, IIIB or IV
PATIENT CHARACTERISTICS: Age: 21 or under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic:
Bilirubin less than 2 times upper normal limit Renal: Not specified Other: Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Less than one week of steroids for management of airway complications Radiotherapy: No prior radiotherapy except emergency radiation to the mediastinum Surgery: Not specified
Study Chair: | Cindy Schwartz, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000065359, COG-9425 |
Study First Received: | May 2, 2000 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00005578 History of Changes |
Health Authority: | United States: Federal Government |
stage II childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma cardiac toxicity |
Anti-Inflammatory Agents Prednisone Immunologic Factors Hodgkin Lymphoma, Childhood Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Etoposide phosphate Hormones Razoxane Anti-Bacterial Agents Etoposide Hodgkin Disease Lymphoma Alkylating Agents |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hodgkin Lymphoma, Adult Vincristine Hodgkin's Disease Antimitotic Agents Cardiovascular Agents Bleomycin Immunosuppressive Agents Glucocorticoids Doxorubicin Lymphatic Diseases Tubulin Modulators Chelating Agents Antineoplastic Agents, Alkylating |
Anti-Inflammatory Agents Prednisone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Razoxane Therapeutic Uses Lymphoma Hodgkin Disease Alkylating Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vincristine Antimitotic Agents Cardiovascular Agents Glucocorticoids Bleomycin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms |