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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.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
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
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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Colorectal Cancer
Intervention  Drug: BCG vaccine
Drug: alum adjuvant
Drug: monoclonal antibody 105AD7 anti-idiotype vaccine
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  April 2000
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United Kingdom
Administrative Information Fields
NCT ID  NCT00007826
Organization ID CDR0000068071
Secondary IDs †† ONYVAX-SGCRO01, NCI-V00-1599
Study Sponsor  Onyvax Limited at St. George's Hospital Medical School
Collaborators ††
Investigators 
Study Chair:     Fiona J. Lofts, MD     St. George's Hospital    
Information Provided By National Cancer Institute (NCI)
Verification Date February 2005
First Received Date  January 6, 2001
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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