In our Phase I trial of recombinant leukocyte interferon (1981-82) in patients with a variety of disseminated cancers, we demonstrated that this agent could be administered up to doses of 50 x 50 million/meter 2 i.m. 3 times weekly without unacceptable toxicity. This trial also showed objective evidence of antitumor response (partial remissions) in some patients with non-Hodgkin's lymphoma, breast cancer, chronic lymphocytic leukemia and Hodgkin's disease. We decided to initiate a Phase II efficacy trial of recombinant leukocyte interferon at a maximum tolerated dose, with dose reductions as necessary for unacceptable toxicity. Phase II efficacy trials were initiated in patients with various lymphoproliferative disorders, including non-Hodgkin's lymphoma, chronic lymphocytic leukemia and cutaneous T-cell lymphoma, as well as patients with refractory metastatic breast cancer. Eighteen patients with metastatic breast cancer were treated in 1982 with recombinant leukocyte A interferon, with 16 patients progressing while on therapy and 2 remaining stable. Eighty-four patients with a variety of lymphomas have been treated, with a 56% response rate in 24 patients with favorable-histology lymphoma (9 partial responses, 5 complete responses) and a 45% response rate in 20 patients with cutaneous T-cell lymphoma (9 partial responses). Only 2 of 19 patients with chronic lymphocytic leukemia and 3 of 16 patients with unfavorable-histology lymphoma responsed. Our currently active studies include randomizing favorable-histology lymphoma patients to low-dose daily recombinant interferon-Alpha (3 million) versus 60 million twice per week to see if the well tolerated low-dose regimen is as efficacious as the high dose schedule. We are also treating patients with hairy cell leukemia with daily doses of recombinant interferon-Alpha (3 million with excellent clinical results (13 responses among our first 14 patients).

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Intramural Research (Z01)
Project #
1Z01CM009233-04
Application #
4692211
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
4
Fiscal Year
1985
Total Cost
Indirect Cost
Name
Cancer Treatment
Department
Type
DUNS #
City
State
Country
United States
Zip Code