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.
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
Last updated: 08/03/2012
NCT ID: NCT00107198
IRB Number:06-002802
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