Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer
19 Years
N/A
Both
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer
Trial Information
Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2
(deleted CH2 region) in patients with colorectal cancer.
II. Determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and
conjugate stability of this drug in these patients.
III. Determine the ability of this drug to localize to tumor sites in these patients.
IV. Determine the immune response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients 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 maximum tolerated dose (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.
Patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease
progression.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities
Outcome Time Frame:
6 weeks
Safety Issue:
Yes
Principal Investigator
Ruby Meredith
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Alabama at Birmingham
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02406
NCT ID:
NCT00023933
Start Date:
October 2001
Completion Date:
Related Keywords:
- Adenocarcinoma of the Colon
- Adenocarcinoma of the Rectum
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Stage IV Colon Cancer
- Stage IV Rectal Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Colonic Neoplasms
- Rectal Neoplasms
Name | Location |
|---|---|
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
