Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2005 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Onyvax Limited at St. George's Hospital Medical School
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00007826
First received: January 6, 2001
Last updated: February 6, 2009
Last verified: February 2005
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: BCG vaccine Biological: monoclonal antibody 105AD7 anti-idiotype vaccine Drug: alum adjuvant |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | April 2000 |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the colon or rectum
- Not amenable to curative surgery and either refractory to or inappropriate for chemotherapy
- Patient must have received adequate or appropriate prior chemotherapy for metastatic disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other prior malignancy within the past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ
- No history of immunodeficiency
- No concurrent unstable medical condition that would preclude study
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 month since prior immunomodulatory drugs
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- At least 1 month since prior corticosteroids
- No concurrent corticosteroids
Radiotherapy:
- At least 6 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 4 weeks since other prior anticancer drug
- No other concurrent investigational anticancer agent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007826
Locations
| United Kingdom | |
| St. George's Hospital | |
| London, England, United Kingdom, SW17 0QT | |
Sponsors and Collaborators
Onyvax Limited at St. George's Hospital Medical School
Investigators
| Study Chair: | Fiona J. Lofts, MD | St. George's Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00007826 History of Changes |
| Other Study ID Numbers: | CDR0000068071, ONYVAX-SGCRO01, NCI-V00-1599 |
| Study First Received: | January 6, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II colon cancer stage III colon cancer stage IV colon cancer stage II rectal cancer |
stage III rectal cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Additional relevant MeSH terms:
|
Adenocarcinoma Colorectal Neoplasms Colonic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Aluminum Hydroxide Aluminum sulfate BCG Vaccine Antibodies Immunoglobulins Antibodies, Monoclonal Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013