Chemotherapy in Treating Patients With Advanced Kidney Cancer

NCT ID: NCT00011973

Last Updated: 2013-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31
• Study Completion Date: 2005-10-31

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.

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.

Conditions

Kidney Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

fenretinide

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Ulka N. Vaishampayan, MD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

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. doi: 10.1007/s10637-005-5864-7.

Reference Type: RESULT

PMID: 15744595 (View on PubMed)

Other Identifiers

U01CA062487

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-C-2232

Identifier Type: -

Identifier Source: secondary_id

NCI-WSU-910

Identifier Type: -

Identifier Source: secondary_id

CDR0000068465

Identifier Type: -

Identifier Source: org_study_id