- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00030342
Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer
A Phase I/II Study Of Interleukin-12-Primed Activated T Cells In Combination With 5FU, GM-CSF And Interferon Alfa-2b In Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine the safety of a repeat course of interleukin-12-primed activated T cells (12ATC) in combination with fluorouracil, sargramostim (GM-CSF), and interferon alfa-2b in patients with metastatic renal cell or colorectal carcinoma.
- Determine the clinical responses of patients treated with this regimen.
- Determine the efficacy of 12ATC in these patients.
- Determine whether there are changes in immunologic parameters related to 12ATC as measured by lymphocyte phenotype and cytokine secretion in these patients.
- Determine the correlation between clinical responses in patients treated with this regimen and in vitro immune functions of lymphocytes.
OUTLINE: Patients are stratified according to disease type (renal cell carcinoma vs colorectal carcinoma).
Patients receive sargramostim (GM-CSF) subcutaneously (SC) daily on days 1-5 and then undergo collection of autologous peripheral blood mononuclear cells (PBMC) on days 6 and 7 of week 1. The PBMC are treated ex vivo to form interleukin-12-primed activated T cells (12ATC).
Patients receive fluorouracil IV over 24 hours on day 6 of week 2 and interferon alfa-2b SC and GM-CSF SC 3 times weekly on weeks 3-5. Patients receive 12ATC IV over 15-30 minutes twice weekly and interferon alfa-2b SC (at least 24 hours after 12ATC infusion) once weekly on weeks 6-8. Patients with complete or partial response or stable disease at 3 weeks after the last 12ATC infusion may receive an additional 8-week course as above.
Patients are followed every 2-3 months for 1 year and then every 6 months for 2 years or at any time when the physical examination or symptoms are suspicious for tumor progression.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 2-3 years.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53215
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Survival as measured by the Kaplan-Meier method at 5 years
|
Response as measured by RECIST guidelines and Kaplan-Meier method at 5 years
|
Safety as measured by NCI common toxicity table at study completion
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: John P. Hanson, MD, St. Luke's Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Fluorouracil
- Sargramostim
Other Study ID Numbers
- STLMC-IMM-0104
- CDR0000069153 (Registry Identifier: PDQ (Physician Data Query))
- STLMC-L-01108
- NCI-V01-1686
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Kidney Cancer
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnKidney/Urinary Cancer
-
PfizerCompletedKidney Cancer | Kidney Neoplasms | Renal Cell Carcinoma | Renal Cancer | Renal Cell Cancer | Cancer of the Kidney | Cancer of KidneyFinland
-
Tianjin Medical University Second HospitalRecruiting
-
Cedars-Sinai Medical CenterRecruitingProstate Cancer Stage II | Prostate Cancer Stage I | Bladder Cancer Stage II | Kidney Cancer Stage IUnited States
-
Tianjin Medical University Second HospitalRecruiting
-
Dana-Farber Cancer InstituteCompletedKidney Cancer | Prostate Cancer | Genitourinary CancerUnited States
-
Intuitive SurgicalCompleted
-
University of Texas Southwestern Medical CenterCompletedKidney Cancer | Kidney Cancer Metastatic | Kidney Cancer, Stage IVUnited States
-
Yale UniversityCompleted
-
Stanford UniversityNational Cancer Institute (NCI)WithdrawnProstate Cancer | Bladder Cancer | Kidney Tumor
Clinical Trials on recombinant interferon alfa
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBladder Cancer | Urethral CancerUnited States
-
Seoul National University HospitalHanyang UniversityRecruitingCoronary Artery Disease | Stable Angina | Acute Myocardial InfarctionKorea, Republic of
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedBreast Cancer | Metastatic CancerUnited States
-
Institute of Hematology & Blood Diseases Hospital...RecruitingEssential ThrombocytopeniaChina
-
Hoffmann-La RocheCompletedRenal Cell Carcinoma | Chronic Myelogenous Leukemia | Malignant MelanomaCanada, India, Bulgaria, Russian Federation, Spain, South Africa, Slovakia
-
Institute of Hematology & Blood Diseases Hospital...RecruitingEssential ThrombocytopeniaChina
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI); NCIC Clinical Trials Group; Children's Oncology... and other collaboratorsActive, not recruitingMelanoma (Skin)United States, Canada, Australia, South Africa
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)SuspendedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Symptomatic COVID-19 Infection Laboratory-ConfirmedUnited States
-
Institute of Cancer Research, United KingdomCompletedMelanoma (Skin)United Kingdom