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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE August 27, 2014
First Posted Date  ICMJE August 29, 2014
Last Update Posted Date August 29, 2014
Study Start Date  ICMJE May 1994
Actual Primary Completion Date October 1994   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
  • Injection Site Reaction [ Time Frame: Through Week 12 ]
    An examination was performed to assess injection site tolerability at every posttreatment visit.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
Intra-gastric pH [ Time Frame: Through Week 8 ]
Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer
Official Title  ICMJE Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Biological: G17DT
Other Name: Polyclonal Antibody Stimulator
Study Arms  ICMJE
  • Experimental: 100µg dose of G17DT
    Patients in this arm received a 100µg dose of G17DT via intramuscular injection.
    Intervention: Biological: G17DT
  • Experimental: 200µg dose of G17DT
    Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.
    Intervention: Biological: G17DT
  • Experimental: 500µg dose of G17DT
    Patients in this arm received a 500µg dose of G17DT via intramuscular injection.
    Intervention: Biological: G17DT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2014)
5
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 1994   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02228785
Other Study ID Numbers  ICMJE CC1C
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cancer Advances Inc.
Study Sponsor  ICMJE Cancer Advances Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: J D Hardcastle, MChir, FRCP, FRCS University of Nottingham
PRS Account Cancer Advances Inc.
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP