Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of tributyrin in treating patients with refractory stage IV prostate cancer or other solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

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

Details

• Lead Sponsor: National Cancer Institute (NCI); University of Maryland, Baltimore
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven prostate cancer or other solid tumor that is refractory to standard treatment or for which no standard therapy exists

• Patients with prostate cancer must meet the following conditions:

• Stage D2 disease

• Disease progression after orchiectomy or treatment with leuprolide or flutamide

• If no prior orchiectomy, must continue leuprolide or other antiandrogen throughout study

• No CNS neoplasms or brain metastases

PATIENT CHARACTERISTICS:

• Age: 18 and over

• Performance status: ECOG 0-2

• Life expectancy: More than 3 months

• WBC at least 3,000/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin at least 9 g/dL

• Bilirubin no greater than 1.5 mg/dL

• AST and ALT no greater than 1.5 times normal

• Creatinine no greater than 1.5 mg/dL OR creatinine clearance greater than 50 mL/min

• No concurrent medical or psychiatric condition that would preclude study

• Able to swallow numerous capsules

• Willing to participate in pharmacokinetic studies

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior chemotherapy (more than 8 weeks since prior carmustine, mitomycin, or other drugs with delayed toxic effects) and recovered

• No prior suramin

• At least 4 weeks since prior flutamide

• No concurrent hydrocortisone or other steroids

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent palliative radiotherapy