NCT00003585

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of biological therapy plus chemotherapy in treating patients with metastatic or recurrent kidney cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 1996

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

August 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
2 years until next milestone

First Posted

Study publicly available on registry

July 22, 2004

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

5 years

First QC Date

November 1, 1999

Last Update Submit

December 9, 2013

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancer

Interventions

aldesleukinBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
fluorouracilDRUG
isotretinoinDRUG
surgical procedurePROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven metastatic and/or recurrent renal cell carcinoma Bidimensionally measurable disease No concurrent brain metastases Patients with prior brain metastases who have undergone radiation and/or surgery, with stable response, confirmed by MRI, and off corticosteroids are eligible PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious illness or active infection requiring antibiotics Not HIV positive No active substance abuse PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior interleukin-2 therapy At least 6 months since prior interferon alfa therapy At least 1 month since other prior biologic therapy No other concurrent biologic therapy (e.g., filgrastim or sargramostim) Chemotherapy: At least 6 months since prior fluorouracil therapy At least 1 month since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At least 1 month since prior endocrine therapy No concurrent hormone therapy No concurrent corticosteroids except if inhaled or topical Radiotherapy: At least 1 month since prior radiotherapy (to less than 25% of the bone marrow only, and there must be measurable disease outside of radiation field) No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery Other: No concurrent ongoing therapy with investigational drugs

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

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Cancer Research & Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

aldesleukinInterferon-alphaFluorouracilIsotretinoinSurgical Procedures, Operative

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)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, Biological

Study Officials

  • Laurence Elias, MD

    University of New Mexico Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 22, 2004

Study Start

August 1, 1996

Primary Completion

August 1, 2001

Study Completion

August 1, 2002

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

US(1)