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

NCT00007826 | Unknown Phase 1

• 3 other identifiers: CDR0000068071ONYVAX-SGCRO01NCI-V00-1599
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Interventions

BCG vaccine BIOLOGICAL

monoclonal antibody 105AD7 anti-idiotype vaccine BIOLOGICAL

alum adjuvant DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Onyvax: lead

Study Sites (1)

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

BCG Vaccine; Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Study Officials

• Fiona J. Lofts, MD

  St. George's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2000
• Last Updated: September 20, 2013

Record last verified: 2005-02

Locations

GB (1)