Under this incrementally funded 5-year award, the contractor will perform a minimum of two Phase I or Phase II clinical trials annually. Each clinical trial will assess the anti-tumor activity and biological mechanism(s) of action of a cytokine or other immunomodulator (alone or in combination with other such agents or standard therapies). The agent(s) of interest will be selected and provided by the NCI for each study. The clinical protocol for each trial will be developed by the contractor in collaboration with staff of the Biological Response Modifiers Program, NCI, and protocols must have NCI and FDA approval before they can be activated. Performance and results of each trial will be closely monitored by NCI professional staff, with tabulation of data by the NCI contract Clinical Trials Monitoring Service.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM087290-006
Application #
3615988
Study Section
Project Start
1988-09-30
Project End
1993-09-29
Budget Start
1992-06-24
Budget End
1993-05-09
Support Year
Fiscal Year
1992
Total Cost
Indirect Cost
Name
University of Wisconsin Madison
Department
Type
Schools of Medicine
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715
Albertini, M R; Hank, J A; Schiller, J H et al. (1997) Phase IB trial of chimeric antidisialoganglioside antibody plus interleukin 2 for melanoma patients. Clin Cancer Res 3:1277-88
Albertini, M R; Gan, J; Jaeger, P et al. (1996) Systemic interleukin-2 modulates the anti-idiotypic response to chimeric anti-GD2 antibody in patients with melanoma. J Immunother Emphasis Tumor Immunol 19:278-95
Mahvi, D M; Madsen, J A; Witt, P L et al. (1995) Interferon alpha enhances expression of TAG-72 and carcinoembryonic antigen in patients with primary colorectal cancer. Cancer Immunol Immunother 40:311-4