Status:
UNKNOWN
Alemtuzumab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV T-Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Toronto Sunnybrook Regional Cancer Centre
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
OBJECTIVES: Primary * Establish the safety and dose-limiting toxicities of alemtuzumab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) chemotherap...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00363090
Start Date
September 1 2006
Last Update
September 20 2013
Active Locations (5)
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1
St. Paul's Hospital at Providence Health Care - Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
2
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, N6A 4L6
3
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
4
Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5