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Chemotherapy in Treating Patients With Advanced Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fenretinide
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 Measurable disease 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: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2 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 fenretinide No other concurrent uncontrolled illness (e.g., ongoing or active infection) No concurrent psychiatric illness or social situation that would preclude study History of HIV allowed if no active infection or history of retinitis No history of retinal disease, night blindness, or difficulty seeing in the dark PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: Recovered from prior therapy No prior systemic retinoid therapy No concurrent antioxidants (e.g., ascorbic acid or vitamin E) No other concurrent therapy for renal cell carcinoma

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute
  • Mayo Clinic Cancer Center
  • University of Pennsylvania Cancer Center
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 3, 2001
Last Updated
April 3, 2013
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00011973
Brief Title
Chemotherapy in Treating Patients With Advanced Kidney Cancer
Official Title
A Phase Two Study Of Fenretinide In Renal Cell Cancer
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

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 fenretinide in treating patients who have advanced kidney cancer.
Detailed Description
OBJECTIVES: Determine the response rate of patients with advanced renal cell carcinoma treated with fenretinide. Determine progression-free and overall survival of this patient population treated with this drug. Determine the quantitative and qualitative toxic effects of this drug in these patients. OUTLINE: Patients receive oral fenretinide twice a day for 7 days. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study within 9-21 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)
fenretinide

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 Measurable disease 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: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2 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 fenretinide No other concurrent uncontrolled illness (e.g., ongoing or active infection) No concurrent psychiatric illness or social situation that would preclude study History of HIV allowed if no active infection or history of retinitis No history of retinal disease, night blindness, or difficulty seeing in the dark PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: Recovered from prior therapy No prior systemic retinoid therapy No concurrent antioxidants (e.g., ascorbic acid or vitamin E) No other concurrent therapy for renal cell carcinoma
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
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15744595
Citation
Vaishampayan U, Heilbrun LK, Parchment RE, Jain V, Zwiebel J, Boinpally RR, LoRusso P, Hussain M. Phase II trial of fenretinide in advanced renal carcinoma. Invest New Drugs. 2005 Mar;23(2):179-85. doi: 10.1007/s10637-005-5864-7.
Results Reference
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Chemotherapy in Treating Patients With Advanced Kidney Cancer

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