Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

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.

Eligibility: 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

Relevance to patient case: not relevant