Active — Not RecruitingPhase 2

Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease

United States188 participantsStarted 2006-01-02

Plain-language summary

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.

Who can participate

Age range1 Month – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with newly diagnosed, previously untreated, biopsy-proven lymphocyte predominant Hodgkin disease (LPHD) are eligible for this protocol as follows: * Diagnosis of LPHD must be made using the Revised European American Lymphoma (REAL)/World Health Organization (WHO) classification criteria and will be confirmed by rapid pathology central review * Clinical stages as follows: * Stage IA without bulk disease * Stage IIA without bulk disease * Patients with "B" symptoms or bulk disease are NOT eligible for this study * Slides for rapid central pathology review must be sent to the Biopathology Center (BPC) * Serum glutamic oxalo-acetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 times upper limit of normal (ULN) * Total bilirubin =\< 1.5 times ULN * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min * 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…

What they're measuring

Failure-free Survival (FFS)

Timeframe: At 5 years

Trial details

NCT IDNCT00107198

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2015-10-06

Results submitted2016-06-30