Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities

NCT00001568 | Completed Phase 2

• 2 other identifiers: 97006897-C-0068
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50 mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min. Initial dynamic images will be obtained over the heart. Emission imaging will work from the midcervical region down to the perineal region. For CEA scanning, radiolabeled antibody, arcitumomab (IMMU-4), is injected intravenously over 5 min. A single photon emission computed tomography (SPECT) transmission scan is performed over the same regions as the emission scans. Total dose from transmission scans should be no more than 20 mRad per patient visit. Patients then undergo exploratory laparotomy performed by two surgeons, one blinded to the results of the CEA-Scan and PET scan. At the completion of all exploration, all identified disease is biopsied for pathologic analysis and any resectable disease is removed. Patients are followed every 3 months for 1 year, every 6 months for the second year, and then after 3 years.

Conditions

Colorectal Neoplasm

Keywords

Tumors; Detection; Follow-Up; Markers; Radiolabeled

Interventions

2-Fluoro-2-deoxyglucose DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

All patients greater than 18 years old who have had a prior resection of colorectal cancer and are suspected of having recurrent disease. Rising serum CEA levels greater than 6 on two successive tests. Resectable residual or recurrent disease. Patients in the occult arm (Arm 1) must have no visible residual disease in the abdomen at the time of the last surgical exploration. In addition, there must be no imageable definitive site of recurrent disease using conventional imaging modalities including; CT scan of chest/ abdomen/ pelvis with contrast, MRI scan, and chest x-ray. Patients in arm 2 may have a single site of recurrent or metastatic disease which is resectable but in whom additional sites of disease are not known and no imageable disease other than a solitary site of potentially resectable disease is identified. Patients must have an ECOG performance status of 0-1. Patients must be willing to return to NIH for follow-up. Patients must be able to provide informed consent as demonstrated by the signed consent. Patients must be 2 or more months from abdominal or thoracic surgery. No patients with medical contraindication to abdominal exploration. No patients with recurrent disease detected by conventional imaging studies as outlined above. Metastatic disease localized outside of the abdominal cavity by conventional imaging studies as outlined above. Patients must weigh less than 136 kgs. which is the weight limit for the scanner tables. No patients with previous injection of murine monoclonal antibodies: Human anti-mouse assay (HAMA) will be performed in patients with prior history of receiving murine monoclonal antibodies. No patients that are pregnant or breast feeding. Patients who are HIV + will be excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Minton JP, Hoehn JL, Gerber DM, Horsley JS, Connolly DP, Salwan F, Fletcher WS, Cruz AB Jr, Gatchell FG, Oviedo M, et al. Results of a 400-patient carcinoembryonic antigen second-look colorectal cancer study. Cancer. 1985 Mar 15;55(6):1284-90. doi: 10.1002/1097-0142(19850315)55:63.0.co;2-b.

  PMID: 3971297 BACKGROUND

• Moffat FL Jr, Pinsky CM, Hammershaimb L, Petrelli NJ, Patt YZ, Whaley FS, Goldenberg DM. Clinical utility of external immunoscintigraphy with the IMMU-4 technetium-99m Fab' antibody fragment in patients undergoing surgery for carcinoma of the colon and rectum: results of a pivotal, phase III trial. The Immunomedics Study Group. J Clin Oncol. 1996 Aug;14(8):2295-305. doi: 10.1200/JCO.1996.14.8.2295.

  PMID: 8708720 BACKGROUND

• Sardi A, Agnone CM, Nieroda CA, Mojzisik C, Hinkle G, Ferrara P, Farrar WB, Bolton J, Thurston MO, Martin EW Jr. Radioimmunoguided surgery in recurrent colorectal cancer: the role of carcinoembryonic antigen, computerized tomography, and physical examination. South Med J. 1989 Oct;82(10):1235-44.

  PMID: 2799440 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: February 1, 1997
• Study Completion: October 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-10

Locations

US (1)