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Chemotherapy in Treating Patients With Advanced Kidney Cancer
This study has been completed.
First Received: March 3, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: Barbara Ann Karmanos Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00011973
  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 II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase Two Study Of Fenretinide In Renal Cell Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2000
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.

  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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011973

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
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:
Study ID Numbers: CDR0000068465, WSU-C-2232, NCI-WSU-910
Study First Received: March 3, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00011973     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Anticarcinogenic Agents
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Protective Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Fenretinide
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009