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Monoclonal Antibody F19 in Treating Patients With Advanced or Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004042
Recruitment Status : Completed
First Posted : August 20, 2004
Last Update Posted : July 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 F19 in treating patients who have advanced or metastatic cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: monoclonal antibody F19 Radiation: iodine I 131 monoclonal antibody F19 Phase 1

Detailed Description:

OBJECTIVES: I. Identify the toxicity associated with increasing doses of monoclonal antibody F19 (BIBH-1) administered weekly by intravenous infusion in patients with unresectable, advanced or metastatic fibroblast activation protein-positive colorectal cancer. II. Determine the dose limiting toxicity and maximum tolerated dose of this drug in these patients. III. Measure induction titers of human anti-human antibody to BIBH-1 and correlate immunologic-related clinical effects. IV. Determine the pharmacokinetics, biodistribution, and imaging characteristics of increasing intravenous doses of the drug. V. Document tumor responses in this patient population.

OUTLINE: This is a dose escalation, open label, multicenter study. Patients receive monoclonal antibody F19 (BIBH-1) IV over 60 minutes weekly for 12 weeks. The first, fifth, and ninth treatments are combined with iodine I 131. Patients with stable or responding disease may continue treatment for up to 12 months. The dose of BIBH-1 is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed at 1 month.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 8 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation Study of BIBH-1 in Patients With Advanced or Metastatic Fibroblast Activation Protein-Positive Cancer
Study Start Date : November 1998
Primary Completion Date : July 2001
Study Completion Date : December 2009

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS: Histologically confirmed unresectable, advanced and/or metastatic disease: Colorectal cancer Measurable or evaluable disease Epidemiologically proven fibroblast activation protein positive Failed or refused conventional treatment, and unlikely to derive significant benefit from conventional treatments No active CNS metastases No new or progressive lesions on CT scan, more than 3 months since treatment (i.e., surgery or radiotherapy) for brain metastases, and/or not receiving mitomycin Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: At least 4 months Hematopoietic: Absolute granulocyte count at least 1,500/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: Not pregnant or nursing Fertile patients must use effective contraception No other serious illness No active infections requiring antibiotics No bleeding disorders No other diseases that may potentially interfere with obtaining accurate study results

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No prior murine, chimeric or humanized antibody and/or antibody fragment Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) Endocrine therapy: No concurrent systemic corticosteroids (except for acute management of allergic-type events) No concurrent immunosuppressive agents Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Recovered from surgery Other: At least 4 weeks since other prior investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004042

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Australia, New South Wales
Ludwig Institute for Cancer Research-Sydney Branch
Sydney, New South Wales, Australia, 2006
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Sydney Welt, MD Memorial Sloan Kettering Cancer Center Identifier: NCT00004042     History of Changes
Other Study ID Numbers: BOEH-1152.1
CDR0000066903 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 20, 2004    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: December 2009

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs