A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

— CC1C  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02228785
• Other study ID #: CC1C
• Status: Terminated
• Phase: Phase 2
• First received: August 27, 2014
• Last updated: August 28, 2014
• Start date: May 1994

Study information

• Verified date: August 2014
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. primary completion date: October 1994
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• G17DT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Advances Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injection Site Reaction	An examination was performed to assess injection site tolerability at every posttreatment visit.	Through Week 12	Yes
Primary	Antibody Levels	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.	Through Week 12	No
Secondary	Intra-gastric pH	Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.	Through Week 8	No