Search / Trial NCT00001570

A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Trial Information

Current as of November 03, 2024

Completed

Keywords

Cytochrome P 450 Multi Drug Resistance P Glycoprotein Pharmacokinetics

ClinConnect Summary

The Phase I clinical trial of the combination of 120-hour continuous intravenous infusion of vinblastine with oral PSC 833 has shown activity in patients with advanced malignancies, particularly renal cell cancer. The MTD of vinblastine in combination with the oral drink solution of PSC 833 was determined to be 0.9 mg/m2/day for five days and 12.5 mg/kg po q 12 hours for eight days, respectively. For the soft gel capsule formulation, the MTD was determined to be 0.6 mg/m2/day vinblastine for five days and 4 mg/kg po q 6 hours PSC 833 for eight days. Ataxia was the dose limiting toxicity. Of...

Gender

ALL

Eligibility criteria

  • 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.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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