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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: | NCT00302003 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) and giving them together with radiation therapy may kill more cancer cells.
PURPOSE: This phase III trial is studying how well combination chemotherapy works when given before radiation therapy and/or additional chemotherapy in treating young patients with newly diagnosed Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: filgrastim Drug: cisplatin Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide phosphate Drug: ifosfamide Drug: prednisone Drug: vincristine sulfate Drug: vinorelbine ditartrate Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin's Disease |
Estimated Enrollment: | 400 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma meeting the following criteria:
Stage IA OR stage IIA without bulky disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Frank G. Keller, MD | Mary Babb Randolph Cancer Center at West Virginia University Hospitals |
Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
Study ID Numbers: | CDR0000459962, COG-AHOD0431 |
Study First Received: | March 9, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00302003 History of Changes |
Health Authority: | United States: Federal Government |
stage I childhood Hodgkin lymphoma stage II childhood Hodgkin lymphoma childhood lymphocyte depletion Hodgkin lymphoma |
childhood mixed cellularity Hodgkin lymphoma childhood nodular sclerosis Hodgkin lymphoma childhood favorable prognosis Hodgkin lymphoma |
Anti-Inflammatory Agents Antimetabolites Dexamethasone Prednisone Immunologic Factors Hodgkin Lymphoma, Childhood Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Vinblastine Cyclophosphamide Hormones Etoposide phosphate Anti-Bacterial Agents Cisplatin |
Alkylating Agents Hodgkin Disease Lymphoma Etoposide Dexamethasone acetate Cytarabine Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hodgkin Lymphoma, Adult Hodgkin's Disease Vincristine Sclerosis Antimitotic Agents Glucocorticoids Antiviral Agents |
Dexamethasone Anti-Inflammatory Agents Prednisone Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Vinblastine Hormones Therapeutic Uses Etoposide Hodgkin Disease Immunoproliferative Disorders |
Immune System Diseases Antineoplastic Agents, Hormonal Vincristine Glucocorticoids Doxorubicin Neoplasms Vinorelbine Antineoplastic Agents, Phytogenic Antimetabolites Immunologic Factors Antineoplastic Agents Cyclophosphamide Antibiotics, Antineoplastic Etoposide phosphate Lymphoma |