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

Recurrent Rectal Cancer Clinical Trial

Official title:

Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023933
• Other study ID #: NCI-2012-02406
• Secondary ID: UAB 9846CDR00000
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2001
• Last updated: January 24, 2013
• Start date: October 2001

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Colon
• Adenocarcinoma of the Rectum
• Colonic Neoplasms
• Rectal Neoplasms
• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Intervention

Drug:
• iodine I 131 monoclonal antibody CC49-deltaCH2
Given IV

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities		6 weeks	Yes
Secondary	Immune response		Up to 54 weeks	No