Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.

Cancer Advances Inc.0 sites5 target enrollmentMay 1994

ConditionsColorectal Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Cancer Advances Inc.
Enrollment: 5
Primary Endpoint: Antibody Levels
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.

Registry

clinicaltrials.gov

Start Date

May 1994

End Date

October 1994

Last Updated

11 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Cancer Advances Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum.
•Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.
•Life expectancy greater than 3 months.
•Karnofsky Index Score greater than or equal to 50%.
•Written informed consent obtained.

Exclusion Criteria

•Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through Stage I.
•Acute intercurrent illness.
•Patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results.
•Patients who had received any other anticancer therapy within 3 months.
•Factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery.
•Patients immunologically compromised including those on corticosteroid therapy.
•Women of child-bearing age.
•Positive immediate hypersensitivity reaction to skin testing with study medication.
•Patients unable to complete the diary book
•Haematogical Status Haemoglobin count less than 10g/dL White Blood Cell count less than 4.0 x 10\^9/L Platelet count less than 100 x 10\^9/L

Outcomes

Primary Outcomes

Antibody Levels

Time Frame: Through Week 12

Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study.

Injection Site Reaction

Time Frame: Through Week 12

An examination was performed to assess injection site tolerability at every posttreatment visit.