Clinical trial NCT00023933: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-06-20
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities
timeFrame: 6 weeks
Secondary outcomes:
measure: Immune response
timeFrame: Up to 54 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ruby Meredith
role: PRINCIPAL_INVESTIGATOR
References: