Clinical trial · Interventional
Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors
PHASE I STUDY OF THE ORALLY ADMINISTERED BUTYRATE PRODRUG, TRIBUTYRIN, IN PATIENTS WITH SOLID TUMORS
NCT00002677CI-TRIAL-00041438completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| tributyrin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral tributyrin every 8 hours for 3 weeks. Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease may receive additional courses at the discretion of the protocol chairperson. Cohorts of 3-6 patients receive escalating doses of tributyrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
- interventionNames
- Drug: chemotherapy
- Drug: tributyrin
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.