Aminocamptothecin in Treating Patients With Advanced or Recurrent Kidney Cancer

June 20, 2013 updated by: Emory University

A Phase II Study of 9-Amino-20(S)-Camptothecin (9-AC) (NSC 603071) and Evaluation of Drug Resistance in Patients With Advanced Renal Cell Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with stage III, stage IV, or recurrent kidney cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the response rate, duration of response, and survival of patients with advanced renal cell carcinoma treated with aminocamptothecin colloidal dispersion. II. Determine the nature and degree of toxicity of aminocamptothecin in this patient population.

OUTLINE: Patients receive aminocamptothecin colloidal dispersion intravenously for 120 hours weekly for 2 weeks followed by 1 week of rest. Courses are repeated every 3 weeks in the absence of disease progression or dose limiting toxicity. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and yearly thereafter.

PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 2 years.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital - Atlanta
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven stage III, stage IV, or recurrent renal cell carcinoma Measurable disease No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1500/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL ALT and AST no greater than 2.5 times the institutional normal values Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled systemic infection No other prior or concurrent malignancies except nonmelanoma skin cancer, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast that have been curatively treated No evidence of delirium, confusion, suicidal ideation, or untreated depression

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior cytokines and recovered No more than 1 prior treatment with cytokines (interleukin-2 or interferons) Chemotherapy: No prior cytotoxic chemotherapy No prior aminocamptothecin No other concurrent antineoplastic agents Endocrine therapy: At least 30 days since prior hormone therapy and recovered No more than 1 prior hormone therapy (tamoxifen or medroxyprogesterone) Radiotherapy: Prior radiotherapy allowed if indicator lesion and greater than 15% of marrow producing bone have not been irradiated Surgery: Recovered from prior surgery Other: At least 30 days since other investigational agents No concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 10, 2004

First Posted (Estimate)

September 13, 2004

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

July 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066608
  • EUSM-HIC-748-96
  • NCI-T96-0110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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