Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell 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 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 trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.

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

Details

• Lead Sponsor: Cancer Research UK
• Treatments: Alemtuzumab; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisolone; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of peripheral T-cell lymphoma (PTCL), including the following subtypes:

• PTCL not otherwise specified

• Angioimmunoblastic T-cell lymphoma

• Anaplastic lymphoma kinase-negative anaplastic large cell lymphoma

• Intestinal T-cell lymphoma

• Bulky stage IA and stages IB-IV disease (Ann Arbor staging system)

• Expression of CD52 by the tumor

• Measurable or evaluable disease

• No anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma

• No CNS involvement with non-Hodgkin lymphoma

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• No presence of other serious, uncontrolled medical conditions

• No significant anthracycline-related cardiac impairment

• LVEF ≥ 50%

• Creatinine ≤ 1.5 mg/dL

• Bilirubin ≤ 2 times normal value unless due to disease

• Not pregnant or nursing

• Fertile patients must use effective barrier contraception during and for 1 month after completion of study treatment

• No previous malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia

• No positive serology or non-consenting to test for any of the following:

• HIV

• Hepatitis B or C

• Human T-lymphotropic virus type 1 (HTLV-1)

PRIOR CONCURRENT THERAPY:

• No prior cytotoxic chemotherapy

• Prior radiotherapy may be allowed at the trial coordinator's discretion

• Concurrent consolidation radiotherapy may be given at the clinician's discretion