Chemotherapy in Treating Patients With Advanced Kidney Cancer

Barbara Ann Karmanos Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Kidney Cancer

Treatments: Drug: fenretinide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00011973

WSU-C-2232

P30CA022453 (U.S. NIH Grant/Contract)

U01CA062487 (U.S. NIH Grant/Contract)

NCI-WSU-910

CDR0000068465

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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