Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease
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 disease (LPHD). Surgery may be an effective treatment for LPHD. 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.
Childhood Lymphocyte Predominant Hodgkin Lymphoma
Stage I Childhood Hodgkin Lymphoma
Stage II Childhood Hodgkin Lymphoma
Drug: doxorubicin hydrochloride
Procedure: conventional surgery
Drug: vincristine sulfate
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)|
- Failure-free survival (FFS) rate [ Time Frame: At 5 years ] [ Designated as safety issue: No ]The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: Disseminated disease (> Stage I/II) progression or recurrence at any time. Local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT. Occurrence of a second malignant neoplasm. Death from any cause.
- Primary toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Survival rate [ Time Frame: From the start of treatment to time of death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
- Cure by surgery alone, AV-PC x 3 alone, or AV-PC x 3 + IFRT [ Time Frame: Up to 12 weeks after completion of therapy ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (surgery, combination chemotherapy, radiotherapy)
COMBINATION CHEMOTHERAPY: Patients receive doxorubicin hydrochloride IV over 10-30 minutes and cyclophosphamide IV over 1 hour on day 1, vincristine sulfate IV over 1 minute on days 1 and 8, and prednisone PO 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 CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy.
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).
Drug: doxorubicin hydrochloride
Other Names:Procedure: conventional surgery
Other Name: surgery, conventionalDrug: cyclophosphamide
Other Names:Drug: prednisone
Given IV or PO
Other Names:Drug: vincristine sulfate
Other Names:Radiation: radiation therapy
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