Monoclonal Antibody Therapy in Treating Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Phase I Single Dose-Escalation Study of BIBH-1 in Patients With Colorectal Cancer Scheduled for Surgical Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005616
• Other study ID #: 99-035A
• Secondary ID: CDR0000067753BOE
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2000
• Last updated: June 18, 2013
• Start date: September 1999
• Est. completion date: August 2000

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 therapy in treating patients who have colorectal cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2000
• Est. primary completion date: August 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• conventional surgery

• neoadjuvant therapy

• radionuclide imaging

Radiation:
• iodine I 131 monoclonal antibody F19

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,