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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00007826
• Other study ID #: CDR0000068071
• Secondary ID: ONYVAX-SGCRO01NC
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: January 6, 2001
• Last updated: September 19, 2013
• Start date: April 2000

Study information

• Verified date: February 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• BCG vaccine

• monoclonal antibody 105AD7 anti-idiotype vaccine

Drug:
• alum adjuvant

Locations

Country	Name	City	State
United Kingdom	St. George's Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Onyvax

Country where clinical trial is conducted

United Kingdom,