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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00656123 |
Purpose
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 |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Biological: GM-K562 cell vaccine Biological: allogeneic tumor cell vaccine Drug: cyclophosphamide Genetic: gene expression analysis Genetic: protein analysis Other: immunoenzyme technique Other: immunologic technique Other: laboratory biomarker 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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000589230, JHOC-J0745, JHOC-NA_00009345 |
| Study First Received: | April 9, 2008 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00656123 History of Changes |
| Health Authority: | Unspecified |
|
adenocarcinoma of the colon adenocarcinoma of the rectum stage IV colon cancer stage IV rectal cancer liver metastases |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Cyclophosphamide Rectal Diseases Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis |
Alkylating Agents Digestive System Neoplasms Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Myeloablative Agonists Gastrointestinal Neoplasms Antineoplastic Agents, Alkylating Antirheumatic Agents Colorectal Neoplasms |