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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
Est. completion date
Est. primary completion date
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


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, 

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