Rebeccamycin Analog in Treating Patients With Advanced Kidney Cancer

April 3, 2013 updated by: Barbara Ann Karmanos Cancer Institute

A Phase II Study of Rebeccamycin Analog in Renal Cell Cancer

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 rebeccamycin analog in treating patients who have advanced kidney cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the response rate of patients with advanced renal cell carcinoma when treated with rebeccamycin analogue.
  • Assess the quantitative and qualitative toxicities associated with this drug in this patient population.

OUTLINE: Patients receive rebeccamycin analogue IV over 30-60 minutes daily for 5 days. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 9-18 months.

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
    • Michigan
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute

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 or cytologically confirmed locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma not eligible for a higher priority trial

  • Measurable disease

    • Longest diameter at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan

  • No nonmeasurable disease only including:

    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Lymphangitis cutis/pulmonis
    • Abdominal masses not confirmed and followed by imaging techniques
    • Cystic lesions

  • No known brain metastases

    • History of brain metastases that have been resected and/or irradiated with subsequent normal brain CT scan allowed

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • Greater than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST/ALT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue
  • No other concurrent uncontrolled illness (e.g., ongoing or active infection)
  • No concurrent psychiatric illness or social situation that would preclude study compliance
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior biologic therapy allowed
  • Recovered from toxic effects

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent investigational or commercial agents or therapies for renal cell cancer

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

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Ulka N. Vaishampayan, MD, Barbara Ann Karmanos Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Ibrahim D, Hussain M, LoRusso P, et al.: Rebeccamycin analog (BMY-27557-14) in renal cell cancer (RCC): preliminary results of a phase II trial. [Abstract] Proceedings of the American Society of Clinical Oncology A-2373, 2001.

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

June 1, 2000

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

August 7, 2003

First Posted (Estimate)

August 8, 2003

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067548
  • P30CA022453 (U.S. NIH Grant/Contract)
  • U01CA062487 (U.S. NIH Grant/Contract)
  • WSU-C-2063
  • NCI-T99-0113

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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