Abstract

The objective of this contract is to provide the NCI with the Phase I, Pharmacokinetic and Phase II/III clinical evaluations of investigational new drugs. Specifically the Contractor shall 1) define the acute toxicities of new anticancer agents in patients with advanced cancer; 2) define the dose of each agent which can be safely given in subsequent Phase II studies of drug activity; 3) provide information on the pharmacologic characteristics (absorption, distribution, metabolism and elimination) of selected antitumor agents; 4) explore the potential uses of pharmacokinetic analysis for optimizing scheduling and dose escalation procedures in a Phase I trial; 5) determine the spectrum of activity of new agents across a variety of human cancers in patients with minimal prior therapy; and 6) establish the role of a new compound, alone or in combination, in selected human cancers compared to standard therapy.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM057732-004
Application #
3613260
Study Section
Project Start
1985-06-01
Project End
1990-04-30
Budget Start
1987-04-08
Budget End
1988-02-28
Support Year
Fiscal Year
1987
Total Cost
Indirect Cost

  Institution

Name
Memorial Hospital for Cancer & Allied Di
Department
Type
DUNS #
City
New York
State
NY
Country
United States
Zip Code
10021

  Publications

Muindi, J F; Stevens, Y W; Warrell Jr, R P et al. (1993) In vitro differential metabolism of merbarone by xanthine oxidase and microsomal flavoenzymes. The role of reactive oxygen species. Drug Metab Dispos 21:410-4
Scher, H I; Jodrell, D I; Iversen, J M et al. (1992) Use of adaptive control with feedback to individualize suramin dosing. Cancer Res 52:64-70
Rigas, J R; Tong, W P; Kris, M G et al. (1992) Phase I clinical and pharmacological study of chloroquinoxaline sulfonamide. Cancer Res 52:6619-23
Berger, M Z; Kris, M G; Gralla, R J et al. (1991) Phase II trial of amonafide in patients with stage III and IV non-small-cell lung cancer. Am J Clin Oncol 14:124-6
Muindi, J F; Lee, S J; Baltzer, L et al. (1991) Clinical pharmacology of deoxyspergualin in patients with advanced cancer. Cancer Res 51:3096-101
Casper, E S; Bajorin, D (1990) Phase II trial of carboplatin in patients with advanced melanoma. Invest New Drugs 8:187-90
Ginn, D; Kelsen, D; Eisenberger, M et al. (1990) Phase II trial of carboplatin and vinblastine in adenocarcinoma of the stomach. Invest New Drugs 8:321-4
Bajorin, D; Kelsen, D P (1990) A phase I trial of combination chemotherapy employing carboplatin, vinca alkaloids, with or without bleomycin in patients with advanced malignant tumors. Cancer Invest 8:135-41
Kris, M G; D'Acquisto, R W; Gralla, R J et al. (1989) Phase II trial of trimetrexate in patients with stage III and IV non-small-cell lung cancer. Am J Clin Oncol 12:24-6
Kemeny, N; Schneider, A; Martin, D S et al. (1989) Phase I trial of N-(phosphonacetyl)-L-aspartate, methotrexate, and 5-fluorouracil with leucovorin rescue in patients with advanced cancer. Cancer Res 49:4636-9

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