Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
Completed · Phase 1
Conditions studied: Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer
In brief
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
Key facts
- Study ID
- NCT00023933
- Run by
- National Cancer Institute (NCI)
- People needed
- 15
- Starts
- 2001-10-01
- Last updated by the study team
- 2013-01-25
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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