Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for treating anaplastic large cell lymphoma.

PURPOSE: This randomized phase III trial is studying several different regimens of combination chemotherapy to compare how well they work in treating children with anaplastic large cell lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Cortisol succinate; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Etoposide; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Ifosfamide; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Methotrexate; Vinblastine

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven standard-risk (SR) or high-risk (HR) anaplastic large cell lymphoma

• SR disease defined by no involvement of the skin, mediastinum, liver, spleen, or lung

• HR disease defined by any of the following:

• Biopsy proven skin lesions (except skin lesions overlying an involved node or isolated skin disease)

• Mediastinal involvement by x-ray or CT scan

• Involvement of the liver (enlarged by at least 5 cm and/or nodular), spleen (enlarged and/or nodular), or lung (biopsy not needed for obvious lesions)

• Histologic or cytologic slides must be available for national pathology review for all patients not meeting the classical criteria for diagnosis (typical histopathology, immunohistochemistry: CD30 positive, endomysial antibody positive, nucleophosmin negative, anaplastic lymphoma kinase (ALK) positive (if available), null or T-immunophenotype) unless proven t(2;5)

• Must enroll within 1 week prior to beginning study regimen A

• No CNS involvement (CSF or cerebral tumor)

• First randomization (SR or HR disease):

• Must have begun prephase therapy

• No isolated primary skin disease

• No low-risk disease defined as completely resected stage I disease

• Second randomization (HR disease only):

• Must have completed first randomization therapy without disease progression

PATIENT CHARACTERISTICS:

Age:

• Under 22

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• See Disease Characteristics

Renal:

• Not specified

Pulmonary:

• See Disease Characteristics

Immunologic:

• No congenital immunodeficiency

• No AIDS

Other:

• No prior malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Prior corticosteroids for anaplastic large cell lymphoma allowed if given for no more than 8 days

Radiotherapy:

• Not specified

Surgery:

• No prior organ transplantation

Other:

• No other prior therapy for anaplastic large cell lymphoma