Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer - Full Text View

Sponsor:	Onyvax Limited at St. George's Hospital Medical School
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00007826

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Biological: BCG vaccine Biological: monoclonal antibody 105AD7 anti-idiotype vaccine Drug: alum adjuvant	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Aluminum sulfate Immunoglobulins BCG Vaccine Globulin, Immune

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 2000

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007826

Locations

United Kingdom, England
St. George's Hospital
London, England, United Kingdom, SW17 0QT

Sponsors and Collaborators

Onyvax Limited at St. George's Hospital Medical School

Investigators

Study Chair:

Fiona J. Lofts, MD

St. George's Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068071, ONYVAX-SGCRO01, NCI-V00-1599
Study First Received:	January 6, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00007826 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

BCG Vaccine
Neoplasms by Histologic Type
Digestive System Neoplasms
Immunologic Factors
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Adjuvants, Immunologic
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms

Carcinoma
Antibodies, Monoclonal
Antibodies
Neoplasms
Aluminum sulfate
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Immunoglobulins
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009