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
18 Years
N/A
Both
Colorectal Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Fiona J. Lofts, MD
Investigator Role:
Study Chair
Investigator Affiliation:
St. George's Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000068071
NCT ID:
NCT00007826
Start Date:
April 2000
Completion Date:
Related Keywords:
- Colorectal Cancer
- 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
- Adenocarcinoma
- Colorectal Neoplasms
- Colonic Neoplasms
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