AHOD03P1: Treatment of Children with Newly Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease
Date Last Modified:
Date First Published: 06/27/2006
| Type | Status | Age Range (yrs.) | Sponsor | Protocol ID |
|---|
| Treatment | Active | 21 and under | COG | AHOD03P1 |
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.
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.
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.
Entry Criteria
- Histologically confirmed low 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
Performance status
Life expectancy
Hematopoietic
Hepatic
- AST or ALT less than 2.5 times upper limit of normal (ULN)
- Bilirubin at least 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
Chemotherapy
Endocrine therapy
- More than 30 days since prior systemic corticosteroids
Radiotherapy
- No prior radiotherapy
- No concurrent intensity modulated radiotherapy
Surgery
Who should I contact for more information?
Rebecca Turner, MS
Cincinnati Children's Hospital Medical Center
Division of Hematology / Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org
