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A Phase Two Study Of Fenretinide In Renal Cell Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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Trial Information

A Phase Two Study Of Fenretinide In Renal Cell Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ulka N. Vaishampayan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068465

NCT ID:

NCT00011973

Start Date:

December 2000

Completion Date:

October 2005

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104