Expired Study
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Detroit, Michigan 48201


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.

Study summary:

OBJECTIVES: - Evaluate the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and sargramostim (GM-CSF) followed by monoclonal antibody OKT3- activated T lymphocytes and interleukin-2 in combination with standard therapy in terms of response rate in patients with stage III or IV colon cancer. - Determine the immunogenicity of colon cancer in this patient population. 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.


DISEASE CHARACTERISTICS: - Histologically proven stage III or IV colon cancer - Resectable disease - At least 50,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - SWOG 0 or 1 Life expectancy: - At least 6 months Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least lower limit of normal - No active or recent uncontrolled bleeding Hepatic: - Bilirubin normal - SGOT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: - Creatinine normal Other: - Negative stool guaiac - No impaired immunity - No uncontrolled diabetes - No active uncontrolled infections - No other serious disease - No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - At least 2 weeks since prior therapy and recovered

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Biological Therapy Following Surgery and Chemotherapy in Treating Patients With Stage III or Stage IV Colon Cancer

Official Title:

Immunotherapy for Colon Carcinoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:

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Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Roy D. Baynes, MD, PhD, FACP
Study Chair
Barbara Ann Karmanos Cancer Institute

Study Dates

Start Date:June 1997
Primary Completion Date:January 2004
Primary Completion Type:Actual
Verification Date:September 2009
Last Changed Date:September 24, 2009
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Intervention Type:Biological
Name:autologous tumor cell vaccine
Intervention Type:Biological
Intervention Type:Biological
Name:therapeutic autologous lymphocytes
Intervention Type:Drug
Intervention Type:Procedure
Name:surgical procedure

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Barbara Ann Karmanos Cancer Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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