Chemotherapy in Treating Patients With Advanced Kidney Cancer
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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 fenretinide in treating patients who have advanced kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: fenretinide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase Two Study Of Fenretinide In Renal Cell Cancer |
| Study Start Date: | December 2000 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Pennsylvania | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Ulka N. Vaishampayan, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00011973 History of Changes |
| Other Study ID Numbers: | CDR0000068465, U01CA062487, P30CA022453, WSU-C-2232, NCI-WSU-910 |
| Study First Received: | March 3, 2001 |
| 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 Fenretinide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013