search
Back to results

Rebeccamycin Analog in Treating Patients With Advanced Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
becatecarin
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
April 3, 2013
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00005027
Brief Title
Rebeccamycin Analog in Treating Patients With Advanced Kidney Cancer
Official Title
A Phase II Study of Rebeccamycin Analog in Renal Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
becatecarin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulka N. Vaishampayan, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result

Learn more about this trial

Rebeccamycin Analog in Treating Patients With Advanced Kidney Cancer

We'll reach out to this number within 24 hrs