Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
This study is currently recruiting patients.
Sponsored by: |
Onyvax |
Information provided by: |
National Cancer Institute (NCI) |
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
|
Treatment or Intervention |
Phase |
Colon Cancer Rectal Cancer
|
Drug: BCG Drug: alum adjuvant Drug: monoclonal antibody 105AD7 anti-idiotype vaccine Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: monoclonal antibody therapy Procedure: non-specific immune-modulator therapy Procedure: non-tumor cell derivative vaccine Procedure: vaccine therapy
|
Phase I Phase II
|
MedlinePlus related topics: Colorectal Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of Monoclonal Antibody 105AD7 Anti-Idiotype Vaccine and ONYCR1, ONYCR2, and ONYCR3 Allogeneic Adenocarcinoma
Cell-Based Vaccines in Patients With Locally Advanced or Metastatic Adenocarcinoma of the Colon or Rectum
Further Study Details:
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 above,
Genders Eligible for Study:
Both
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
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
Location
and Contact
Information
United Kingdom, England St. George's Hospital, London,
England,
SW17 0QT,
United Kingdom; Recruiting
Fiona J. Lofts, MD
44-20-8725-0231
Study chairs or principal investigators
Fiona J. Lofts, MD, Study Chair, St. George's Hospital
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000068071; ONYVAX-SGCRO01; NCI-V00-1599
Record last reviewed:
December 2001
Record first received:
January 6, 2001
ClinicalTrials.gov Identifier:
NCT00007826Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-10