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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: | NCT00025259 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
PURPOSE: This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease.
Condition | Intervention | Phase |
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Lymphoma |
Drug: bleomycin Drug: cisplatin Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: prednisone Drug: vincristine sulfate Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Group-Wide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease |
Estimated Enrollment: | 1000 |
Study Start Date: | September 2002 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I (for patients with SER): Active Comparator
Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, and cytarabine IV over 3 hours on days 1-2 and cisplatin IV over 6 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After these 2 courses, patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients then undergo radiotherapy.
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Drug: bleomycin
Given IV or subcutaneously
Drug: cisplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given IV
Drug: dexamethasone
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: filgrastim
Given subcutaneously
Drug: prednisone
Given orally
Drug: vincristine sulfate
Given IV
Procedure: radiation therapy
Patients undergo radiotherapy.
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Arm II (for patients with SER): Experimental
Patients receive 2 additional courses of ABVE-PC chemotherapy. Patients then undergo radiotherapy.
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Drug: bleomycin
Given IV or subcutaneously
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: filgrastim
Given subcutaneously
Drug: prednisone
Given orally
Drug: vincristine sulfate
Given IV
Procedure: radiation therapy
Patients undergo radiotherapy.
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OBJECTIVES:
OUTLINE: This is a randomized, multicenter study.
At the end of initial chemotherapy, patients undergo evaluation for response. Patients with less than 60% disease reduction are considered to have slow early response (SER). Patients with 60% or more disease reduction are considered to have rapid early response (RER).
SER: Patients with SER are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within 5-5.5 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed Hodgkin's lymphoma
May not be staged by laparotomy alone
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: | Debra L. Friedman, MD | Children's Hospital and Regional Medical Center, Seattle |
Study ID Numbers: | CDR0000068943, COG-AHOD0031 |
Study First Received: | October 11, 2001 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00025259 |
Health Authority: | Unspecified |
stage II childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma childhood lymphocyte predominant Hodgkin lymphoma |
childhood lymphocyte depletion Hodgkin lymphoma childhood nodular sclerosis Hodgkin lymphoma childhood mixed cellularity Hodgkin lymphoma childhood nodular lymphocyte predominant Hodgkin lymphoma |
Dexamethasone Prednisone Immunoproliferative Disorders Hodgkin's disease Hodgkin lymphoma, adult Vincristine Sclerosis Cyclophosphamide Bleomycin Etoposide phosphate |
Doxorubicin Lymphatic Diseases Cisplatin Hodgkin lymphoma, childhood Lymphoproliferative Disorders Etoposide Lymphoma Hodgkin Disease Cytarabine Dexamethasone acetate |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Antibiotics, Antineoplastic Hormones Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type |
Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Gastrointestinal Agents Antimitotic Agents Immunosuppressive Agents Antiviral Agents Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents |