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Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
This study is ongoing, but not recruiting participants.
Study NCT00007826   Information provided by National Cancer Institute (NCI)
First Received: January 6, 2001   Last Updated: February 6, 2009   History of Changes

January 6, 2001
February 6, 2009
April 2000
 
 
 
Complete list of historical versions of study NCT00007826 on ClinicalTrials.gov Archive Site
 
 
 
Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
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

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.

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.

Phase I, Phase II
Interventional
Treatment, Open Label
Colorectal Cancer
  • Biological: BCG vaccine
  • Biological: monoclonal antibody 105AD7 anti-idiotype vaccine
  • Drug: alum adjuvant
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00007826
 
CDR0000068071, ONYVAX-SGCRO01, NCI-V00-1599
Onyvax Limited at St. George's Hospital Medical School
 
Study Chair: Fiona J. Lofts, MD St. George's Hospital
National Cancer Institute (NCI)
February 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP