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A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer (CC1C)

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ClinicalTrials.gov Identifier: NCT02228785
Recruitment Status : Terminated (Poor local tolerance to injection.)
First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Cancer Advances Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: G17DT Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.
Study Start Date : May 1994
Actual Primary Completion Date : October 1994

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 100µg dose of G17DT
Patients in this arm received a 100µg dose of G17DT via intramuscular injection.
 Biological: G17DT
Other Name: Polyclonal Antibody Stimulator
Experimental: 200µg dose of G17DT
Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.
 Biological: G17DT
Other Name: Polyclonal Antibody Stimulator
Experimental: 500µg dose of G17DT
Patients in this arm received a 500µg dose of G17DT via intramuscular injection.
 Biological: G17DT
Other Name: Polyclonal Antibody Stimulator


Outcome Measures
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Primary Outcome Measures :
  1. Injection Site Reaction [ Time Frame: Through Week 12 ]
    An examination was performed to assess injection site tolerability at every posttreatment visit.

  2. 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.


Secondary Outcome Measures :
  1. Intra-gastric pH [ Time Frame: Through Week 8 ]
    Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228785


Sponsors and Collaborators
Cancer Advances Inc.
Investigators
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Principal Investigator: J D Hardcastle, MChir, FRCP, FRCS University of Nottingham
More Information
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Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT02228785     History of Changes
Other Study ID Numbers: CC1C
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Gastrins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs