3-AP in Treating Patients With Advanced or Metastatic Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of 3-AP in treating patients with advanced or metastatic solid tumors. 3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Criteria:

• Must be able to swallow

• Histologically confirmed solid tumor

• Advanced or metastatic disease

• Measurable or evaluable disease

• No known active CNS metastases

• ECOG performance status 0-1

• Life expectancy > 3 months

• Progressive disease during >= 1 prior standard therapy OR disease unlikely to respond to any currently available therapies

• Patients with previously treated CNS metastases who have no evidence of new CNS metastases AND are stable for >= 2 months are eligible

• Platelet count >= 100,000/mm^3

• Hemoglobin >= 10 g/dL (transfusions allowed)

• Absolute neutrophil count >= 1,500/mm^3

• ALT and AST =< 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase =< 2.5 times ULN

• Creatinine =< 1.5 mg/dL OR creatinine clearance >= 50 mL/min

• Bilirubin normal

• PT/PTT =< 1.5 times ULN

• FEV1 >= 1.2 L

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception 2 weeks prior to and during study treatment

• No mental deficits and/or psychiatric history that may preclude study treatment

• No active heart disease, including any of the following: myocardial infarction within the past 3 months, symptomatic coronary artery disease or heart block, uncontrolled congestive heart failure

• No moderate to severe compromise of pulmonary function

• No active infection

• No other life-threatening illness

• No active coagulation disorder other than occult blood

• No known positivity for glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Recovered from prior treatment

• Prior gemcitabine allowed

• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• More than 3 weeks since prior radiotherapy or any other treatment for this cancer

• No prior 3-AP

• No concurrent radiotherapy

• No other concurrent investigational agent