Lymphoma Clinical Trial
Official title:
Alemtuzumab and CHOP Chemotherapy for Aggressive Histology Peripheral T Cell Lymphomas: A Multi-Centre Phase I and II Study
Verified date | June 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario |
Canada | London Regional Cancer Program at London Health Sciences Centre | London | Ontario |
Canada | Odette Cancer Centre at Sunnybrook | Toronto | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital at Providence Health Care - Vancouver | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Toronto Sunnybrook Regional Cancer Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity as assessed by NCI Common Toxicity Criteria Version 3.0 | Yes | ||
Primary | Safety | Yes | ||
Primary | Dose-limiting toxicities | Yes | ||
Primary | Pharmacokinetics of alemtuzumab | No | ||
Secondary | Efficacy as assessed by clinical, radiologic, pathologic, and laboratory measurements | No | ||
Secondary | Overall response rate | No | ||
Secondary | Progression-free survival | No | ||
Secondary | Overall survival | No | ||
Secondary | Effects of treatment on T- and B-cell reconstitution by flow cytometry at baseline and at 3, 6, and 12 months | No |
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