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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004020 |
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and chemotherapy in treating patients who have stage III or stage IV colon cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Biological: aldesleukin Biological: autologous tumor cell vaccine Biological: muromonab-CD3 Biological: therapeutic autologous lymphocytes Drug: chemotherapy Procedure: surgical procedure |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Immunotherapy for Colon Carcinoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy |
Study Start Date: | June 1997 |
OBJECTIVES:
OUTLINE: Patients are stratified according to extent of disease, extent of antigen specific response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender.
Patients undergo surgical debulking of tumor on week 1 followed by adjuvant chemotherapy. Within 2-4 weeks of chemotherapy, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF), then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 2 weeks later.
Patients undergo peripheral blood mononuclear cell collection two weeks after the second vaccination. Peripheral blood mononuclear cells are stimulated with anti-CD3 monoclonal antibody (OKT3) and interleukin-2, producing activated T lymphocytes. The activated T lymphocytes are infused IV over 1-6 hours followed by 5 doses of interleukin-2 IV every other day over 10 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients may receive one additional course of immunotherapy as above.
Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven stage III or IV colon cancer
Resectable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 |
Study Chair: | Roy D. Baynes, MD, PhD, FACP | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000067239, WSU-C-1403-CO, NCI-G99-1563 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004020 History of Changes |
Health Authority: | United States: Federal Government |
stage III colon cancer stage IV colon cancer recurrent colon cancer |
Anti-HIV Agents Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Antiviral Agents Immunosuppressive Agents Rectal Diseases Recurrence |
Intestinal Neoplasms Muromonab-CD3 Carcinoma Digestive System Diseases Aldesleukin Anti-Retroviral Agents Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |
Anti-Infective Agents Anti-HIV Agents Digestive System Neoplasms Immunologic Factors Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Intestinal Diseases Antiviral Agents Immunosuppressive Agents Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Muromonab-CD3 Neoplasms Aldesleukin Neoplasms by Site Digestive System Diseases Anti-Retroviral Agents Therapeutic Uses Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |