Clinical trial · Interventional
A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer
- 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)
Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous infusion of PSC 833, followed by another continuous infusion lasting an additional 6 days. To ensure the safety of a 7 day infusion of PSC 833, one patient is treated for 5 days and a second for 6 days, before the first cohort is enrolled. Vinblastine is administered in escalating doses on days 2-5. At least 3 patients are entered at each dose level. The MTD will be defined as the dose immediately below that at which 2 patients experience dose limiting toxicity. Treatment continues every 28 days.
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 |
|---|---|---|---|
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSC 833 | Drug | — | UNRESOLVED |
| vinblastine | Drug | Vinblastine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven renal cancer with clear cell component: Measurable or evaluable disease; No brain metastases; No grade 2 or greater peripheral neuropathy or neurologic toxicity symptoms. PRIOR/CONCURRENT THERAPY: Biologic Therapy: Not specified. Chemotherapy: No prior or concurrent hypersensitivity to PSC 833 or cyclosporine A. Endocrine Therapy: Not specified. Radiotherapy: No prior radiation therapy within 4 weeks of study. Surgery: No major surgery within 4 weeks of study. Other: No concurrent treatments that interfere with cyclosporine blood concentrations. PATIENT CHARACTERISTICS: Age: 18 and over. Performance Status: ECOG 0-2. Life Expectancy: At least 16 weeks. Hematopoietic: ANC greater than or equal to 1500/mm(3); Platelet count greater than or equal to 100,000/mm(3). Hepatic: Bilirubin no greater than 1.5 x normal; AST no greater than 2.5 x normal. Renal: Creatinine no greater than 2.0 mg/dL OR; Creatinine clearance greater than or equal to 50 mL/min. Cardiovascular: No concurrent angina or myocardial infarction that has not been appropriately treated. Other: Not pregnant or nursing. Effective contraceptive required of all fertile patients. Patients with a history of curatively treated basal cell or squamous cell carcinoma are eligible. No HIV seropositivity. No chronic hepatitis or cirrhosis. Patients with concurrent reversible conditions such as diabetes, hypercalcemia, hyperuricemia, hyperviscosity, infection, renal disease, or spinal cord compression are eligible with appropriate therapy. Patients must give written informed consent.
References
Publications (3)
- BACKGROUNDChapman AE, Goldstein LJ. Multiple drug resistance: biologic basis and clinical significance in renal-cell carcinoma. Semin Oncol. 1995 Feb;22(1):17-28. No abstract available. PMID 7855615
- BACKGROUNDBoote DJ, Dennis IF, Twentyman PR, Osborne RJ, Laburte C, Hensel S, Smyth JF, Brampton MH, Bleehen NM. Phase I study of etoposide with SDZ PSC 833 as a modulator of multidrug resistance in patients with cancer. J Clin Oncol. 1996 Feb;14(2):610-8. doi: 10.1200/JCO.1996.14.2.610. PMID 8636778
- BACKGROUNDTwentyman PR. MDR1 (P-glycoprotein) gene expression--implications for resistance modifier trials. J Natl Cancer Inst. 1992 Oct 7;84(19):1458-60. doi: 10.1093/jnci/84.19.1458. No abstract available. PMID 1359150