Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

Phase 1TerminatedNCT00006046

Ludwig Institute for Cancer Research7 enrolled

Overview

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 advanced colorectal cancer.

OBJECTIVES: * Determine the toxicity, maximum tolerated dose, and pharmacokinetics of monoclonal antibody hu3S193 in patients with advanced colorectal carcinoma. * Determine the immune response in these patients treated with this regimen. OUTLINE: This is a dose escalation study. Patients receive monoclonal antibody hu3S193 (mAb hu3S193) IV over 30 minutes to 4 hours weekly for 8 weeks followed by 2 weeks of rest. Patients with stable or responding disease at week 10 receive maintenance mAb hu3S193 weekly. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of mAb hu3S193 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

monoclonal antibody hu3S193BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven stage IV colorectal carcinoma. * Failed or refused conventional chemotherapy. * Lewis Y antigen present on more than 50% of tumor cells. * Measurable or evaluable disease. * No central nervous system (CNS) tumor involvement. * Karnofsky 80-100%. * Life expectancy: At least 6 weeks. * Granulocyte count greater than 1,500/mm\^3. * Platelet count greater than 100,000/mm\^3. * Bilirubin no greater than 1.0 mg/dL. * Prothrombin time less than 3 times upper limit of normal. * Creatinine no greater than 1.4 mg/dL. * Female patients of childbearing age and male patients must be asked to use effective contraception during the study. * At least 4 weeks since other prior immunotherapy. Exclusion Criteria * New York Heart Association class III or IV heart disease. * Serious infection requiring antibiotics or other serious illness. * Pregnancy or nursing. * History of bleeding gastric ulcers or pancreatitis. * Diabetes mellitus requiring insulin. * Human antimouse antibodies (HAMA). * No prior mouse monoclonal antibody or antibody fragments. * Illness requiring the use of steroids or other anti-inflammatory agents. * Positive anti-hu3S193 antibody (HAHA) titer.

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Number of Patients With Dose-limiting Toxicities (DLTs)

Toxicity was graded in accordance with the Common Toxicity Scale developed by NCI (1998) where Grade 1 represents the lowest toxicity grade and Grade 5 death. Dose-limiting toxicity (DLT) was defined as Grade 3 and Grade 4 adverse events which were at least possibly related to study treatment.

Time frame: up to 10 weeks.

Secondary Outcomes

Number of Patients With Tumor Responses

Complete response (CR); disappearance of all measurable disease lasting a minimum of 4 weeks. Partial Response (PR); 50% or greater decrease in the sum of the products of the perpendicular diameters or all measurable lesions, without development of new lesions or increase in size of any lesion, lasting a minimum of 4 weeks. Progressive disease (PD); Appearance of new lesions or increase by 25% or more in size of any measurable lesion. Stable disease (SD); Not meeting criteria for response or progression.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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