Status:
COMPLETED
S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, 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 o...
Detailed Description
OBJECTIVES: Primary * Determine the 2-year progression-free survival rate in patients with newly diagnosed mantle cell lymphoma treated with induction therapy comprising rituximab, cyclophosphamide,...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria:
- Stage III-IV or bulky stage II disease
- Confirmation of positivity for the following phenotypes by immunohistochemistry or flow cytometry:
- Cluster of differentiation antigen 19 (CD19) (or CD20)
- Cyclin D1 OR evidence of t(11;14) translocation by cytogenetic analysis or fluorescent in situ hybridization
- Newly diagnosed, previously untreated disease
- Bidimensionally measurable disease by conventional techniques
- No nonmeasurable disease only
- Adequate tumor tissue from original diagnostic specimen available
- Tissue obtained by needle aspiration or cytology not allowed
- No clinical evidence of central nervous system (CNS) involvement by lymphoma
- Co-registration on protocols SWOG-8947 and SWOG-8819 is strongly encouraged
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No peripheral neuropathy ≥ grade 2
- No hypersensitivity to bortezomib, boron, or mannitol
- No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease free for the past 5 years
- HIV negative
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
- More than 14 days since prior investigational drugs
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00376961
Start Date
August 1 2006
End Date
September 1 2017
Last Update
November 6 2017
Active Locations (147)
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1
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
2
Providence Cancer Center
Anchorage, Alaska, United States, 99508
3
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
4
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205