Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
This trial is active, not recruiting.
|Treatments||bcg vaccine, monoclonal antibody 105ad7 anti-idiotype vaccine, alum adjuvant|
|Phase||phase 1/phase 2|
|Sponsor||Onyvax Limited at St. George's Hospital Medical School|
|Start date||April 2000|
|Trial identifier||NCT00007826, CDR0000068071, NCI-V00-1599, ONYVAX-SGCRO01|
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.
Male or female participants at least 18 years old.
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
|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|
|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.|
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