Trial record 6 of 74 for:    "Kidney Neoplasms" AND (woman OR women OR female)

A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001302
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: June 2002
  Purpose

The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in-vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study is to define the maximum tolerated dose in combination with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine. PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent cycles both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.


Condition Intervention Phase
Breast Cancer
Kidney Neoplasm
Lymphoma
Neoplasm Metastasis
Ovarian Cancer
Drug: PSC 833
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 80
Study Start Date: September 1992
Estimated Study Completion Date: June 2002
Detailed Description:

The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study is to define the maximum tolerated dose in combination with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine. PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent cycles both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Biopsy proven metastatic cancer, for whom no better therapy exists. All patients are eligible. Enrollment of patients with kidney, breast, ovarian cancers, and lymphomas is encouraged.

A life expectancy of at least 16 weeks, and a performance status (Karnofsky scale) of 70% or greater. Patients without rapidly growing disease.

Any prior therapy except for previous bone marrow transplantation.

WBC greater than 3,000/mm3 and ACG greater than 1,000/mm3; platelets greater than 100,000/mm3.

Creatinine Clearance greater than 50 ml/min; bilirubin less than 1.5 mg/dl; SGOT less than 70u/L; SGPT less than 80u/L.

A signed informed consent and geographic accessibility for the patient to return for follow up and treatment.

No history of brain metastases.

Not currently receiving treatment with the following agents or any other agent known to significantly interact with cyclosporine, and treatment cannot be discontinued, or changed to another therapeutically equivalent allowable drug: acetazolamide, barbiturates, corticosteroids, diltiazem, erythromycin, fluconazole, ketoconazole, nicardipine, phenothiazines, phenytoin, rifampin, sulfonamides, trimethoprim, verapamil, tamoxifen, progesterone, quinine, quinidine, or amiodarone.

No symptomatic peripheral neuropathy (grade 2 or greater arising from prior vinca alkaloid therapy).

No positive serology for HIV.

No ongoing pregnancy or unwillingness to practice adequate contraception.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001302

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001302     History of Changes
Other Study ID Numbers: 920268, 92-C-0268
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Vinblastine
Multidrug Resistance
Resistance Reversal
Pgp Blocker
Pharmacokinetics
Cyclosporine
Drug Interactions

Additional relevant MeSH terms:
Kidney Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Breast Neoplasms
Ovarian Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplastic Processes
Pathologic Processes
Urologic Neoplasms
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014