Chemotherapy in Treating Patients With Advanced Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

A Phase Two Study Of Fenretinide In Renal Cell Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00011973
• Other study ID #: CDR0000068465
• Secondary ID: U01CA062487P30CA
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2001
• Last updated: April 3, 2013
• Start date: December 2000
• Est. completion date: October 2005

Study information

• Verified date: April 2013
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• fenretinide

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vaishampayan U, Heilbrun LK, Parchment RE, Jain V, Zwiebel J, Boinpally RR, LoRusso P, Hussain M. Phase II trial of fenretinide in advanced renal carcinoma. Invest New Drugs. 2005 Mar;23(2):179-85. — View Citation