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Chemotherapy in Treating Patients With Advanced Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00011973
Recruitment Status : Completed
First Posted : August 8, 2003
Last Update Posted : April 5, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Barbara Ann Karmanos Cancer Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: fenretinide Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase Two Study Of Fenretinide In Renal Cell Cancer
Study Start Date : December 2000
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011973


Locations
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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
National Cancer Institute (NCI)
Investigators
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Study Chair: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00011973     History of Changes
Other Study ID Numbers: CDR0000068465
U01CA062487 ( U.S. NIH Grant/Contract )
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-C-2232
NCI-WSU-910
First Posted: August 8, 2003    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013
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:
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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