Clinical trial NCT00011973: Chemotherapy in Treating Patients With Advanced Kidney Cancer
Official title: A Phase Two Study Of Fenretinide In Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Ulka N. Vaishampayan, MD
role: STUDY_CHAIR
References:
citation: 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.