Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer

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

Summary

Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent metastatic colorectal cancer. Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins; Iodine

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic adenocarcinoma of the colon or rectum

• Not amenable to surgical resection

• Recurrent or persistent disease after standard surgery, radiotherapy, and chemotherapy, including fluorouracil and irinotecan

• TAG-72 positive

• Performance status - ECOG 0-2

• WBC greater than 3,500/mm^3

• Platelet count greater than 125,000/mm^3

• Hemoglobin greater than 10 g/dL

• No nucleated RBC or significant teardrop RBC morphology

• Bilirubin less than 1.5 mg/dL

• SGOT/SGPT less than 4 times normal

• Hepatitis B surface antigen negative

• Creatinine less than 2.0 mg/dL

• HIV negative

• No other malignancy within the past 5 years except basal cell skin cancer

• No allergy to iodine

• No detectable antibody to monoclonal antibody CC49

• Not pregnant or nursing

• Fertile patients must use effective contraception

• At least 3 weeks since prior immunotherapy and recovered

• No prior bone marrow or stem cell transplantation

• No other concurrent immunotherapy

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy and recovered

• No concurrent chemotherapy

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy and recovered

• No prior radiotherapy to more than 25% of red marrow

• No concurrent radiotherapy

• See Disease Characteristics

• At least 3 weeks since prior surgery and recovered