NCT00030342

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 combined with chemotherapy in treating patients who have metastatic kidney cancer or colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 colorectal-cancer

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_1 colorectal-cancer

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

November 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

June 26, 2013

Status Verified

October 1, 2008

Enrollment Period

5.9 years

First QC Date

February 14, 2002

Last Update Submit

June 25, 2013

Conditions

Colorectal CancerKidney Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

  • Response as measured by RECIST guidelines and Kaplan-Meier method at 5 years

  • Survival as measured by the Kaplan-Meier method at 5 years

  • Safety as measured by NCI common toxicity table at study completion

Interventions

recombinant interferon alfaBIOLOGICAL
sargramostimBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
fluorouracilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic renal cell carcinoma or colorectal carcinoma, meeting 1 of the following criteria: * Obtained no benefit from prior standard or salvage therapy * Ineligible for standard therapy because of concurrent illness * Declined standard therapy * At least 1 site of measurable disease that can be measured in at least 1 dimension * At least 20 mm with conventional techniques OR at least 10 mm with spiral CT scan * 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/mm\^3 * Granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL * No coagulation disorders Hepatic: * Bilirubin no greater than 2.5 mg/dL\* * ALT/AST less than 3 times upper limit of normal\* * PT no greater than 1.5 times control (unless therapeutically anticoagulated) * PTT less than 1.5 times control (unless therapeutically anticoagulated) NOTE: \*Patients whose cancer has led to values that do not fall within the above ranges may be eligible at the discretion of the investigators Renal: * Creatinine no greater than 2.0 mg/dL\* NOTE: \*Patients whose cancer has led to values that do not fall within the above range may be eligible at the discretion of the investigators Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No thrombophlebitis Pulmonary: * FEV\_1 and FVC at least 65% predicted * No uncontrolled pulmonary embolism Other: * No other malignancy within the past 5 years except resected basal cell skin cancer or carcinoma in situ of the cervix * No prior allergic reactions attributed to compounds of similar chemical or biologic composition to interleukin-12-primed activated T cells or other study agents * No active autoimmune disease * No uncontrolled thyroid abnormalities * No ongoing or active infection * No other uncontrolled concurrent illness * No psychiatric illness or social situations that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 2 years after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 4 weeks since prior immunotherapy Chemotherapy: * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * At least 4 weeks since prior steroid therapy or steroid-containing compounds * At least 2 weeks since prior topical or inhaled steroids Radiotherapy: * More than 4 weeks since prior radiotherapy and recovered Surgery: * More than 4 weeks since prior major surgery Other: * No other concurrent investigational agents * No other concurrent commercial anticancer agents * No concurrent combination antiretroviral therapy for HIV-positive patients

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

Sponsors & Collaborators

Study Sites (1)

Vince Lombardi Cancer Clinic at Aurora 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

February 14, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

October 1, 2007

Study Completion

January 1, 2008

Last Updated

June 26, 2013

Record last verified: 2008-10

Locations

US(1)