Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over Pharmaceutical / Industry ONYVAX-SGCRO01 NCI-V00-1599, NCT00007826

Objectives

1. 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.
2. Determine any immunological response to these treatment regimens in these patients.
3. Determine the 6-month and 1-year survival of these patients after receiving these treatment regimens.
4. Determine the tumor response to these treatment regimens in these patients.

Entry 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

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

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

Expected Enrollment

A total of 45 patients (15 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Onyvax Limited at St. George's Hospital Medical School

Fiona Lofts, MD, Protocol chair		Ph: 44-20-8725-0231

Registry Information
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
Trial Start Date		2000-04-25
Registered in ClinicalTrials.gov		NCT00007826
Date Submitted to PDQ		2000-06-09
Information Last Verified		2005-02-09