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| Sponsored by: |
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030342 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Kidney Cancer |
Biological: recombinant interferon alfa Biological: sargramostim Biological: therapeutic autologous lymphocytes Drug: fluorouracil |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2001 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic renal cell carcinoma or colorectal carcinoma, meeting 1 of the following criteria:
At least 1 site of measurable disease that can be measured in at least 1 dimension
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Wisconsin | |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Study Chair: | John P. Hanson, MD | Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center |
More Information
| Responsible Party: | Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center ( John P. Hanson, Jr ) |
| Study ID Numbers: | CDR0000069153, STLMC-IMM-0104, STLMC-L-01108, NCI-V01-1686 |
| Study First Received: | February 14, 2002 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00030342 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer stage IV renal cell cancer recurrent renal cell cancer |
|
Antimetabolites Urinary Tract Neoplasm Interferon Type I, Recombinant Interleukin-12 Immunologic Factors Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Urogenital Neoplasms Urologic Neoplasms Rectal Diseases Renal Cancer Urologic Diseases Kidney Neoplasms Kidney Diseases |
Interferon-alpha Kidney Cancer Digestive System Neoplasms Interferons Rectal Neoplasm Intestinal Diseases Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents Intestinal Neoplasms Recurrence Carcinoma Digestive System Diseases Rectal Cancer Fluorouracil |
|
Antimetabolites Anti-Infective Agents Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Urogenital Neoplasms Urologic Neoplasms Rectal Diseases Neoplasms by Site Urologic Diseases |
Kidney Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Interferon-alpha Neoplasms by Histologic Type Digestive System Neoplasms Growth Substances Interferons Intestinal Diseases Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions |