Monoclonal Antibody F19 in Treating Patients With Advanced or Metastatic Cancer

NCT ID: NCT00004042

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-11-30
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Colorectal Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

monoclonal antibody F19

Intervention Type: BIOLOGICAL

iodine I 131 monoclonal antibody F19

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Sydney Welt, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Ludwig Institute for Cancer Research-Sydney Branch

Sydney, New South Wales, Australia

Countries

United States; Australia

Other Identifiers

MSKCC-98068

Identifier Type: -

Identifier Source: secondary_id

CDR0000066903

Identifier Type: REGISTRY

Identifier Source: secondary_id

LUDWIG-LUD98-002

Identifier Type: -

Identifier Source: secondary_id

NCI-H99-0025

Identifier Type: -

Identifier Source: secondary_id

BOEH-1152.1

Identifier Type: -

Identifier Source: org_study_id