Alemtuzumab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV T-Cell Non-Hodgkin's Lymphoma

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

Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed aggressive stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Toronto Sunnybrook Regional Cancer Centre
• Treatments: Alemtuzumab; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed aggressive peripheral T-cell non-Hodgkin's lymphoma (NHL), including the following nodal or extranodal subtypes:

• Nodal:

• Angioimmunoblastic lymphadenopathy

• ALK 1-negative anaplastic large cell NHL

• Peripheral T-cell lymphoma not otherwise specified

• Extranodal:

• Hepatosplenic NHL

• Enteropathy-associated NHL

• Panniculitic NHL

• Stage II-IV disease

• Newly diagnosed, CD52+ disease

• Measurable or evaluable disease

• No known CNS involvement with lymphoma

• No nasal natural killer T-cell NHL

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 4 months

• Absolute neutrophil count ≥ 1,000/mm³*

• Platelet count ≥ 75,000/mm³*

• Hemoglobin ≥ 8.5 g/dL*

• Bilirubin < 2.0 mg/dL

• Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)

• AST or ALT < 2 times ULN

• Creatinine < 1.5 mg/dL*

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known hypersensitivity to any of the study drugs

• No serious illnesses that would preclude compliance with study requirements

• No known HIV positivity

• No other preexisting immunodeficiency (e.g., post-organ transplant)

• No other malignancy within the past 5 years except cervical carcinoma in situ or nonmelanoma skin cancer NOTE: *Unless directly attributable to NHL

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

• Up to 7 days of prednisone preceding initiation of chemotherapy allowed

• No other concurrent chemotherapy, radiotherapy, or immunotherapy

• No other concurrent corticosteroids except dexamethasone used as an antiemetic for a brief period