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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Onyvax
• Treatments: Aluminum Hydroxide; Aluminum sulfate; Antibodies; Antibodies, Monoclonal; BCG Vaccine; Immunoglobulins; Vaccines

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

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