Rebeccamycin Analog in Treating Patients With Advanced Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00005027
First received: April 6, 2000
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: becatecarin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Rebeccamycin Analog in Renal Cell Cancer

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Study Start Date: June 2000
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005027

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
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.

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00005027     History of Changes
Other Study ID Numbers: CDR0000067548, U01CA062487, P30CA022453, WSU-C-2063, NCI-T99-0113
Study First Received: April 6, 2000
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 22, 2014