search
Back to results

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

Primary Purpose

Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
iodine I 131 monoclonal antibody CC49-deltaCH2
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Colon

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (monoclonal antibody)

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities

Secondary Outcome Measures

Immune response

Full Information

First Posted
September 13, 2001
Last Updated
January 24, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00023933
Brief Title
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
Official Title
Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (monoclonal antibody)
Arm Type
Experimental
Arm Description
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 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.
Intervention Type
Drug
Intervention Name(s)
iodine I 131 monoclonal antibody CC49-deltaCH2
Other Intervention Name(s)
131I-HuCC49-deltaCH2, 131I-MOAB CC49-deltaCH2
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Immune response
Time Frame
Up to 54 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruby Meredith
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs