Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma.

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

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Doxorubicin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Prednisone; Vinblastine; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed advanced anaplastic large cell lymphoma

• Cluster of differentiation antigen 30 (CD30+)

• Murphy stage III or IV

• No B-cell large cell lymphoma

• No disease limited to the skin (regardless of how wide-spread)

PATIENT CHARACTERISTICS:

Age

• Under 21

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Aspartate aminotransferase (AST) or alanine transaminase (ALT) less than 2.5 times ULN (unless due to lymphoma)

Renal

• Not specified

Cardiovascular

• Shortening fraction (SF) at least 27% by echocardiogram OR

• Ejection fraction (EF) at least 50% by radionuclide angiogram

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Prior steroids for management of a mediastinal mass allowed

Radiotherapy

• Prior limited-dose radiotherapy for a mediastinal mass allowed

Surgery

• Not specified