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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00302003 |
Purpose
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 |
|---|---|---|
|
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 tartrate Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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.
After completion of study treatment, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Eligibility| 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:
Contacts and Locations
Show 187 Study Locations| Study Chair: | Frank G. Keller, MD | Mary Babb Randolph Cancer Center at West Virginia University Hospitals |
More Information
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00302003 History of Changes |
| Other Study ID Numbers: | CDR0000459962, COG-AHOD0431 |
| Study First Received: | March 9, 2006 |
| Last Updated: | February 26, 2011 |
| 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 |
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Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Etoposide phosphate Isophosphamide mustard Vinorelbine Cisplatin Cyclophosphamide Cytarabine Dexamethasone |
Doxorubicin Etoposide Ifosfamide Prednisone Vincristine Vinblastine Lenograstim Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |