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Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin's Disease
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: April 5, 2005   Last Updated: November 13, 2009   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: Treatment
Official Title: Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin  Disease Lymphoma Surgery
Drug Information available for: Cyclophosphamide Prednisone Vincristine Doxorubicin Doxorubicin hydrochloride Myocet Vincristine sulfate
U.S. FDA Resources

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)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the cure rate in young patients with completely resected stage IA (with a single involved lymph node) lymphocyte predominant Hodgkin's disease (LPHD) who undergo observation only.
  • Determine the cure rate in patients with incompletely resected stage IA, completely resected stage IA (whose disease recurs after observation), or stage IIA LPHD treated with combination chemotherapy comprising doxorubicin, vincristine, prednisone, and cyclophosphamide with or without involved-field radiotherapy.

Secondary

  • Determine the potential for long-term toxicity of these regimens in these patients.

OUTLINE: This is a multicenter, pilot study. Patients are stratified according to level of surgical resection and disease stage (completely resected stage I disease vs incompletely resected stage I disease or stage II disease).

Patients with stage IA disease who underwent confirmed complete resection of a single involved lymph node at diagnosis undergo observation only*.

Patients with stage IA disease who underwent possible complete resection of a single involved lymph node at diagnosis undergo imaging at 6-7 weeks after surgery. Patients with a confirmed complete resection by imaging undergo observation only*. Patients who do not demonstrate complete resection by imaging proceed to combination chemotherapy with or without radiotherapy.

Patients with stage IA disease who underwent a fine needle aspiration of a single involved lymph node OR an incomplete resection of a single involved lymph node at diagnosis may undergo a second surgery to achieve complete resection. Patients who undergo complete resection during the second surgery undergo imaging at 6-7 weeks after surgery. Patients with a confirmed complete resection by imaging undergo observation only*. Patients who do not undergo a second surgery OR do not achieve complete resection with the second surgery proceed to combination chemotherapy with or without radiotherapy.

Patients with stage IA disease with involvement of more than 1 lymph node OR stage IIA disease proceed directly to combination chemotherapy with or without radiotherapy.

NOTE: *Patients with recurrent disease after observation only undergo biopsy and restaging and then proceed to combination chemotherapy with or without radiotherapy.

  • Combination chemotherapy: Patients receive doxorubicin IV over 10-30 minutes and cyclophosphamide IV over 1 hour on day 1, vincristine IV over 1 minute on days 1 and 8, and prednisone orally or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiotherapy.
  • Involved-field radiotherapy (IFRT): Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).

Patients are followed every 3 months for 2 years, every 6 months for 3 years, annually for 5 years, and then every 5 years for 10 years.

PROJECTED ACCRUAL: A total of 150 patients (at least 50 for stratum I and 100 for stratum II) will be accrued for this study within 5 years.

  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 glomerular filtration rate ≥ 70 mL/min OR

  • Creatinine based on age as follows:

    • No greater than 0.8 mg/dL (for patients 5 years of age and under)
    • No greater than 1.0 mg/dL (for patients 6 to 10 years of age)
    • No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
    • No greater than 1.5 mg/dL (for patients 16 to 21 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 140 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
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:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000419921, COG-AHOD03P1
Study First Received: April 5, 2005
Last Updated: November 13, 2009
ClinicalTrials.gov Identifier: NCT00107198     History of Changes
Health Authority: Unspecified

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:
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
Therapeutic Uses
Lymphoma
Hodgkin Disease
Alkylating Agents
Immunoproliferative Disorders
 Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Glucocorticoids
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on November 20, 2009



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