Colorectal Cancer
Conditions
Keywords
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
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Onyvax
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United Kingdom
Outcome results
None listed