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Monoclonal Antibody Therapy in Treating Patients With Colorectal Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center Identifier:
First received: May 2, 2000
Last updated: June 18, 2013
Last verified: June 2013

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have colorectal cancer.

Condition Intervention Phase
Colorectal Cancer Metastatic Cancer Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radionuclide imaging Radiation: iodine I 131 monoclonal antibody F19 Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Single Dose-Escalation Study of BIBH-1 in Patients With Colorectal Cancer Scheduled for Surgical Resection

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Estimated Enrollment: 12
Study Start Date: September 1999
Study Completion Date: August 2000
Primary Completion Date: August 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine any toxicity associated with increasing single doses of monoclonal antibody F19 (BIBH-1) administered by intravenous infusion in patients with colorectal cancer scheduled for surgical resection. II. Compare the pharmacokinetics, biodistribution, and imaging characteristics of increasing intravenous doses of iodine I 131 BIBH-1 in this patient population. III. Compare the BIBH-1 related human antihuman antibody (HAHA) serum concentration with immunologic related clinical effects in these patients. IV. Compare the uptake of iodine I 131 BIBH-1 in tumor to the uptake of normal tissue when administered to these patients.

OUTLINE: This is a dose escalation study. Patients receive monoclonal antibody F19 (BIBH-1) combined with iodine I 131 IV over 60 minutes. Patients undergo surgical resection approximately 7 days after BIBH-1 infusion. Cohorts of 3-6 patients receive escalating doses of BIBH-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed once during days 5-14 and then at day 30 after surgery.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 4 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed primary colorectal cancer Candidate for a clinically indicated laparotomy for primary tumor resection, resection of hepatic metastases, or placement of an intrahepatic arterial catheter No active CNS metastases defined by new or enlarging lesions on CT scan or within 3 months of treatment (i.e., surgery or radiotherapy) for brain metastases No prior participation in this study

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 2,500/mm3 Lymphocyte count greater than 700/mm3 Platelet count at least 100,000/mm3 Hepatic: ALT/AST no greater than 3 times upper limit of normal Bilirubin less than 2 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: No pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No incomplete healing at an incision site as evidenced by incomplete granulation, infection, or localized edema No active infections requiring antibiotics No bleeding disorders No other serious illness that may potentially interfere with obtaining accurate study results No autoimmune disease No hypertrophic skin conditions

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No prior murine, chimeric, or humanized antibody and/or antibody fragment Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent systemic corticosteroids except for acute management of allergic type events Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Recovered from prior surgery Other: At least 4 weeks since other prior investigational agents No concurrent immunosuppressive agents

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Please refer to this study by its identifier: NCT00005616

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Sydney Welt, MD Memorial Sloan Kettering Cancer Center
  More Information Identifier: NCT00005616     History of Changes
Other Study ID Numbers: 99-035A
CDR0000067753 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: May 2, 2000
Last Updated: June 18, 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017