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Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer

Primary Purpose

Colorectal Cancer, Kidney Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa
sargramostim
therapeutic autologous lymphocytes
fluorouracil
Sponsored by
St. Luke's Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
June 25, 2013
Sponsor
St. Luke's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00030342
Brief Title
Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Luke's Medical Center

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Kidney Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous lymphocytes
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Primary Outcome Measure Information:
Title
Response as measured by RECIST guidelines and Kaplan-Meier method at 5 years
Title
Survival as measured by the Kaplan-Meier method at 5 years
Title
Safety as measured by NCI common toxicity table at study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. Hanson, MD
Organizational Affiliation
St. Luke's Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer

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