NCT00011973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2000

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2001

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

August 8, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

4.8 years

First QC Date

March 3, 2001

Last Update Submit

April 3, 2013

Conditions

Kidney Cancer

Keywords

stage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancer

Interventions

fenretinideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

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

    PMID: 15744595RESULT

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Ulka N. Vaishampayan, MD

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2001

First Posted

August 8, 2003

Study Start

December 1, 2000

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

US(4)