NCT00016042

Brief Summary

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

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

April 5, 2004

Completed
Last Updated

September 20, 2013

Status Verified

October 1, 2001

First QC Date

May 6, 2001

Last Update Submit

September 19, 2013

Conditions

Colorectal CancerKidney Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage IV renal cell cancerrecurrent renal cell cancer

Interventions

lymphokine-activated killer cellsBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
sargramostimBIOLOGICAL
fluorouracilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma or colorectal carcinoma Failed prior standard or salvage therapy OR Ineligible for standard therapy due to concurrent illness OR Declined standard therapy Bidimensionally measurable disease (by CT scan or MRI) outside prior irradiation port unless documented disease progression after radiotherapy No untreated or unstable treated brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Total granulocyte count at least 2,000/mm3 Hemoglobin at least 10 g/dL No coagulation disorders such as thrombophlebitis Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT/SGPT less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 3 times ULN PT/PTT no greater than 1.5 times control Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active ischemia and/or ejection fraction less than 45% No unstable angina No uncontrolled congestive heart failure Pulmonary: FEV1 or FVC greater than 65% of predicted No uncontrolled pulmonary embolism Other: No other prior malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix No active systemic infection No autoimmune disease No uncontrolled thyroid abnormalities No other major medical illness HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: More than 1 month since prior biologic therapy or immunotherapy Chemotherapy: More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: At least 4 weeks since prior steroid therapy or steroid-containing compounds At least 2 weeks since prior topical or inhaled steroids No concurrent steroids Radiotherapy: More than 1 month since prior radiotherapy, interstitial brachytherapy, or radiosurgery Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsKidney NeoplasmsColonic NeoplasmsRectal NeoplasmsCarcinoma, Renal Cell

Interventions

Interferon-alphasargramostimFluorouracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale 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 Compounds

Study Officials

  • John P. Hanson, MD

    St. Luke's Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2001

First Posted

April 5, 2004

Study Start

January 1, 2001

Last Updated

September 20, 2013

Record last verified: 2001-10

Locations

US(1)