Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Tumor-Targeting Tracer Plus Surgery in Treating Patients With Recurrent Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over Pharmaceutical / Industry NEO-2-61

Objectives

I. Determine the feasibility of radioimmunoguided surgery/activated cellular 
therapy (RIGS/ACT) in patients with recurrent colorectal cancer who have 
undergone complete resection of intraabdominal disease.

II. Evaluate the safety of the surgical procedure for obtaining appropriate 
lymph nodes for RIGS/ACT, and the safety profile of the infusion of cells.

III. Assess potential relationships between characteristics of the final 
cellular infusion product and safety/efficacy including time and tumor 
recurrence.

Entry Criteria

Disease Characteristics:

Histologically proven adenocarcinoma of the colon or rectum that has recurred
after primary resection

Clinical and radiologic evaluation indicates the potential for secondary
complete resection confined to abdominal cavity

Prior/Concurrent Therapy:

Biologic therapy:
 No prior exposure to murine antibodies with a positive HAMA response
 No concurrent biologic therapy

Chemotherapy:
 At least 4 weeks since chemotherapy 
 No concurrent chemotherapy

Endocrine therapy:
 No concurrent corticosteroids

Radiotherapy:
 At least 4 weeks since radiotherapy
 No concurrent radiopharmaceutical or radiotherapy

Surgery:
 Not specified

Patient Characteristics:

Age:
 18 and over

Performance Status:
 ECOG 0-1

Life Expectancy:
 Not specified

Hematopoietic:
 WBC at least 3,500/mm3
 Platelet count at least 100,000/mm3
 
Hepatic:
 Bilirubin no greater than 1.5 mg/dL

Renal:
 Creatinine no greater than 2 mg/dL

Cardiovascular:
 Adequate cardiac function to tolerate general anesthesia
 No concurrent uncontrolled hypertension
 No postoperative acute myocardial infarction, thromboembolic episode, or     

 cerebrovascular event

Pulmonary:
 Adequate pulmonary function to tolerate general anesthesia

Other:
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use an effective contraceptive method
 No active infection requiring antibiotics
 Not HIV positive
 Not hepatitis B or C positive
 No history of iodine hypersensitivity
 No prior malignancies within the past 10 years, except:
  Localized basal or squamous cell carcinoma of the skin
  Curatively treated carcinoma in situ of the cervix
 No obstructing lesion likely to require surgery within 2-3 weeks of study
 No active peptic ulcers
 No concurrent uncontrolled diabetes

Expected Enrollment

A total of 40 patients will be accrued for this study.

Outline

This is an open label, multicenter study.

Part I: Patients receive intravenous iodine 125 I-CC49 monoclonal antibody 
(MOAB), after initiation of thyroid blockade. Patients undergo surgery 
approximately 3-4 weeks after MAb administration. Patients who are considered 
to have resectable disease undergo intraabdominal lymph node evaluation for 
suitable radioimmunoguided surgery/activated cellular therapy (RIGS/ACT) 
material. Appropriate tumor-draining lymph nodes are resected, and lymphocytes 
are removed and activated in culture using interleukin-2 and anti-CD3 MAb.

Part II: On postoperative days 12-14, a single infusion of activated cells are 
administered to patients as RIGS/ACT therapy.

Patients are followed for up to 5 years posttreatment.

Trial Contact Information

Trial Lead Organizations

Neoprobe Corporation

Patricia A. Coburn, Protocol chair		Ph: 614-793-7500; 800-876-4656