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Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin's Disease
This study is ongoing, but not recruiting participants.

First Received on April 5, 2005.   Last Updated on December 30, 2010   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00107198
  Purpose

RATIONALE: Surgery may be an effective treatment for lymphocyte predominant Hodgkin's disease. Drugs used in chemotherapy, such as doxorubicin, vincristine, prednisone, and cyclophosphamide, 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) with or without radiation therapy may kill more cancer cells.

PURPOSE: This clinical trial is studying how well surgery and/or combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin's disease.


Condition Intervention
Lymphoma
Drug: CHOP regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 150
Study Start Date: January 2006
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed lymphocyte-predominant Hodgkin's disease

    • Stage IA* or IIA* disease NOTE: *No bulky disease.
  • Newly diagnosed, previously untreated disease
  • No B symptoms

PATIENT CHARACTERISTICS:

Age

  • 21 and under

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • AST or ALT < 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR
  • Creatinine based on age/gender as follows:

    • No greater than 0.4 mg/dL (for patients 1 to 5 months of age)
    • No greater than 0.5 mg/dL (for patients 6 to 11 months of age)
    • No greater than 0.6 mg/dL (for patients 1 year of age)
    • No greater than 0.8 mg/dL (for patients 2 to 5 years of age)
    • No greater than 1.0 mg/dL (for patients 6 to 9 years of age)
    • No greater than 1.2 mg/dL (for patients 10 to 12 years of age)
    • No greater than 1.4 mg/dL (for female patients ≥ 13 years of age)
    • No greater than 1.5 mg/dL (for male patients 13 to 15 years of age)
    • No greater than 1.7 mg/dL (for male patients ≥ 16 years of age)

Cardiovascular

  • Ejection fraction ≥ 50% by MUGA OR
  • Shortening fraction ≥ 27% by echocardiogram

Other

  • Not pregnant or nursing*

    • Patients who are pregnant or nursing who have stage IA disease and underwent confirmed complete resection of a single involved lymph node are eligible for observation only
  • Negative pregnancy test *
  • Fertile patients must use effective contraception* NOTE: *For patients receiving study chemotherapy or radiotherapy.

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • More than 30 days since prior systemic corticosteroids

Radiotherapy

  • No prior radiotherapy
  • No concurrent intensity modulated radiotherapy

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107198

  Show 146 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Burton E. Appel, MD Hackensack University Medical Center Cancer Center
Investigator: Cindy Schwartz, MD Hasbro Children's Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00107198     History of Changes
Other Study ID Numbers: CDR0000419921, COG-AHOD03P1
Study First Received: April 5, 2005
Last Updated: December 30, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood lymphocyte predominant Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents
Tubulin Modulators

ClinicalTrials.gov processed this record on February 09, 2012