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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 |
Drug: fluorouracil Drug: recombinant interferon alfa Drug: sargramostim Drug: therapeutic autologous lymphocytes |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Colorectal Cancer Kidney Cancer |
| Drug Information available for: | Sargramostim Granulocyte-macrophage colony-stimulating factor Fluorouracil Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Interleukin-12 |
| 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 | |||||
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center |
| Study Chair: | John P. Hanson, MD | Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Responsible Party: | Medical Consultants, Limited ( John P. Hanson, Jr ) |
| Study ID Numbers: | CDR0000069153, STLMC-IMM-0104, STLMC-L-01108, NCI-V01-1686 |
| First Received: | February 14, 2002 |
| Last Updated: | November 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00030342 |
| Health Authority: | United States: Federal Government |
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