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Status unknownNCT00007826Updated Sep 20, 2013

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

A Phase 1/2 interventional study of BCG vaccine and monoclonal antibody 105AD7 anti-idiotype vaccine in Colorectal Cancer, sponsored by Onyvax. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-20.

Sponsored by Onyvax · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2005), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • 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
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

This is the only study on the registry with Onyvax as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • BiologicalBCG vaccine
  • Biologicalmonoclonal antibody 105AD7 anti-idiotype vaccine
  • Drugalum adjuvant
06

Study locations

1 site
  • St. George's Hospital
    London, England SW17 0QT, United Kingdom
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00007826
Lead sponsor
Onyvax
First posted
Jan 27, 2003
Start date
Apr 2000
Last update
Sep 20, 2013

Study contacts

Fiona J. Lofts, MD
study chair · St. George's Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2005. You cannot join it, but the record below documents what was studied.

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