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 Services.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM097622-002
Application #
3616841
Study Section
Project Start
1990-06-30
Project End
1994-06-29
Budget Start
1990-06-30
Budget End
1991-06-29
Support Year
Fiscal Year
1990
Total Cost
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Type
DUNS #
017730458
City
Cleveland
State
OH
Country
United States
Zip Code
44195
Olencki, T; Finke, J; Tubbs, R et al. (1996) Immunomodulatory effects of interleukin-2 and interleukin-4 in patients with malignancy. J Immunother Emphasis Tumor Immunol 19:69-80