CompletedNCT00023933Updated Jan 25, 2013

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

A Phase 1 interventional study of iodine I 131 monoclonal antibody CC49-deltaCH2 in Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum and Recurrent Colon Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2013-01-25.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 15
Allocation: Not applicable
Ages: 19 Years and older
Sex: All

Study 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

Read the 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.

Conditions studied

Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer

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In context

Colonic Neoplasms

1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.

This study's enrollment of 15 is below the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.

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Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.

Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 15 participants (actual)

Study arms

Experimental
Treatment (monoclonal antibody)
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.
Drug: iodine I 131 monoclonal antibody CC49-deltaCH2

Interventions

Drugiodine I 131 monoclonal antibody CC49-deltaCH2
Given IV
Also known as: 131I-HuCC49-deltaCH2, 131I-MOAB CC49-deltaCH2

What researchers measure

Primary outcomes

Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities
Time frame: 6 weeks

Secondary outcomes

Immune response
Time frame: Up to 54 weeks

Study locations

1 site

University of Alabama at Birmingham
Birmingham, Alabama 35294, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2001 and a primary completion of Jul 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 13, 2001
First posted: Jun 20, 2003
Start: Oct 2001
Primary completionActual: Jul 2005
Last update: Jan 25, 2013

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00023933
Lead sponsor: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jun 20, 2003
Start date: Oct 2001
Primary completion: Jul 2005
Last update: Jan 25, 2013

Study contacts

Ruby Meredith

principal investigator · University of Alabama at Birmingham

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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