Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer
3 other identifiers
interventional
15
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2001
CompletedStudy Start
First participant enrolled
October 1, 2001
CompletedFirst Posted
Study publicly available on registry
June 20, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedJanuary 25, 2013
January 1, 2013
3.8 years
September 13, 2001
January 24, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities
6 weeks
Secondary Outcomes (1)
Immune response
Up to 54 weeks
Study Arms (1)
Treatment (monoclonal antibody)
EXPERIMENTALPatients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8. Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the MTD is determined. The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity.
Interventions
Given IV
Eligibility Criteria
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
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruby Meredith
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2001
First Posted
June 20, 2003
Study Start
October 1, 2001
Primary Completion
July 1, 2005
Last Updated
January 25, 2013
Record last verified: 2013-01