This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. In this NCI-sponsored phase III randomized trial, patients must have stage III/IV follicular lymphoma. They must have lymph nodes 2 cm for resection and harvest of lymphoma for the production of an autologous vaccine. All patients will receive the standard chemotherapy (PACE). If patients attain a clinical response with PACE they will be randomized to receive either KLH vaccine (day 1) + GM-CSF (days 1-4) or KLH control vaccine (day 1) + GM-CSF (days 1-4). Thus, the investigators will determine the effects of immunization with autologous, follicular lymphoma-derived immunoglobulin conjugated to KLH as compared with KLH alone on the ability to induce and sustain clinical complete remission and to eliminate subclinical residual tumor cells, as detected by PCR, following standard initial therapy for this tumor. Preclinical and clinical nonrandomized data support the design of this study. A separate autologous vaccine will be made for each patient. Low-dose GMCSF will be used as adjuvant therapy. The vaccines will be made by the NCI. Immunizations start at least six months after PACE chemotherapy. Five immunizations will be done over 6 months (1, 2, 3, 4, 6 month injections).

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000096-45
Application #
7378272
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
45
Fiscal Year
2006
Total Cost
$2,806
Indirect Cost
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
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