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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00656123 |
RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with chemotherapy may be a more effective treatment for colorectal cancer.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy given together with cyclophosphamide in treating patients who have undergone surgery for liver metastases due to metastatic colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer Metastatic Cancer |
Drug: GM-K562 cell vaccine Drug: allogeneic tumor cell vaccine Drug: cyclophosphamide Procedure: gene expression analysis Procedure: immunoenzyme technique Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: protein analysis |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Clinical Trial of an Allogeneic Colon Cancer Cell Vaccine Administered With a GM-CSF Producing Bystander Cell Line in Patients With Metastatic Colorectal Cancer |
Estimated Enrollment: | 18 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: At least 1 month and no more than 3 months after the last course of adjuvant systemic chemotherapy or hepatic metastectomy, patients receive cyclophosphamide IV on day -1 and vaccine therapy comprising allogeneic colorectal carcinoma cells and K562/GM-CSF cells intradermally on day 0. Treatment repeats every month for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Blood is collected prior to the first vaccine administration, then one month after each (1st through 4th) immunization for correlative studies. Samples are analyzed by ELISPOT assays on peripheral blood mononuclear cells, for HLA typing and HLA-A2 expression by the standard NIH microlymphocytotoxicity test, for peptides by ELISPOT assays, and for immunologic response by other exploratory assays.
After completion of study treatment, patients are followed at 28 days and then periodically thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
Underwent prior complete hepatic metastasectomy and is presently without evidence of cancer (no gross disease following surgery)
Patients* may receive adjuvant systemic chemotherapy of colorectal cancer including, but not limited to, any of the following:
Administration of the investigational product needs to be planned for 1-3 months after the last course of chemotherapy or liver resection
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Prior or currently active autoimmune disease requiring management with systemic immunosuppression, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
More than 28 days since prior systemic corticosteroid treatment via the oral, intramuscular, or intravenous routes
More than 28 days since prior surgery
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Clinical Research Office 410-955-8866 jhcccro@jhmi.edu |
Principal Investigator: | Richard D. Schulick, MD, FACS | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000589230, JHOC-J0745, JHOC-NA_00009345 |
Study First Received: | April 9, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00656123 |
Health Authority: | Unspecified |
adenocarcinoma of the colon adenocarcinoma of the rectum stage IV colon cancer stage IV rectal cancer liver metastases |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Cyclophosphamide Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Rectal neoplasm Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplastic Processes |
Neoplasms by Site Pathologic Processes Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |