Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00007826|
Recruitment Status : Unknown
Verified February 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from cancer cells may make the body build an immune response to kill colorectal tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy and/or vaccine therapy in treating patients who have locally advanced or metastatic colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: BCG vaccine Biological: monoclonal antibody 105AD7 anti-idiotype vaccine Drug: alum adjuvant||Phase 1 Phase 2|
- Determine the safety and tolerability of monoclonal antibody 105AD7 anti-idiotypic vaccine and ONYCR1, ONYCR2, and ONYCR3 allogeneic adenocarcinoma cell-based vaccines in patients with locally advanced or metastatic adenocarcinoma of the colon or rectum.
- Determine any immunological response to these treatment regimens in these patients.
- Determine the 6-month and 1-year survival of these patients after receiving these treatment regimens.
- Determine the tumor response to these treatment regimens in these patients.
OUTLINE: This is an open-label study. Patients are assigned to one of three treatment arms.
- Arm I: Patients receive monoclonal antibody 105AD7 anti-idiotype vaccine (MOAB 105AD7) plus BCG intradermally (ID) weekly for weeks 1 and 2; MOAB 105AD7 ID plus alum adjuvant intramuscularly (IM) weekly for weeks 4 and 6; and then MOAB 105AD7 ID alone monthly for up to 12 months.
- Arm II: Patients receive ONYCR1, ONYCR2, and ONYCR3 allogeneic adenocarcinoma cell-based vaccines plus BCG ID weekly for weeks 1 and 2; these vaccines ID weekly for weeks 4 and 6, and then monthly for up to 12 months.
- Arm III: Patients receive MOAB 105AD7, ONYCR1, ONYCR2, and ONYCR3 allogeneic adenocarcinoma cell-based vaccines, and BCG ID weekly for weeks 1 and 2; MOAB 105AD7 and ONYCR1, ONYCR2, and ONYCR3 allogeneic adenocarcinoma cell-based vaccines ID plus alum adjuvant IM weekly for weeks 4 and 6; and then MOAB 105AD7 and ONYCR1, ONYCR2, and ONYCR3 allogeneic adenocarcinoma cell-based vaccines monthly for up to 12 months.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 45 patients (15 per treatment arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of an Allogeneic Cell Based Vaccine and an Anti-Idiotypic Antibody Vaccine Approach for Metastatic Adenocarcinoma of the Colon or Rectum|
|Study Start Date :||April 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007826
|St. George's Hospital|
|London, England, United Kingdom, SW17 0QT|
|Study Chair:||Fiona J. Lofts, MD||St. George's Hospital|