Multiple drug resistance: biologic basis and clinical significance in renal-cell carcinoma.
A E Chapman, L J Goldstein
https://pubmed.ncbi.nlm.nih.gov/7855615Completed
Phase 1
All Genders
ID00001570
A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer
Led by National Cancer Institute (NCI) · Updated on 2008-03-04
46
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Phase I study of etoposide with SDZ PSC 833 as a modulator of multidrug resistance in patients with cancer.
D J Boote, I F Dennis, P R Twentyman...
https://pubmed.ncbi.nlm.nih.gov/8636778MDR1 (P-glycoprotein) gene expression--implications for resistance modifier trials.
P R Twentyman
https://pubmed.ncbi.nlm.nih.gov/1359150