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Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

Sponsor
Cancer Advances Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02098239
Collaborator
(none)
41
Enrollment
2
Arms
33
Duration (Months)

Study Details

Study Description

Brief Summary

The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Non-Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open, Multiple Dose, Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
Study Start Date :
Aug 1, 1999
Actual Primary Completion Date :
Apr 1, 2002
Study Completion Date :
May 1, 2002

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting.

Drug: G17DT
Other Names:
  • Polyclonal Antibody Stimulator (PAS)

    		•
    Active Comparator: Group B

    Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was <40 μmol/L.

    Drug: G17DT
    Other Names:
  • Polyclonal Antibody Stimulator (PAS)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacodynamic [Weeks 0, 1,3,4,6,8,12, 16+]

      Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.

    2. Patient Survival [Up to week 139]

      The vital status of patients was monitored throughout the study and was followed until death or the end of the study.

    Secondary Outcome Measures

    1. Injection Tolerability [Up to Week 16]

      Tolerability was assessed by injection site during first 16 weeks after the first injection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.

    • If patients were jaundiced, bilirubin had to be >80 μmol/L.

    • Male or female patients over 18 years of age.

    • World Health Organization (WHO) performance status of 0 to 2.

    • Patients with a life expectancy of at least 8 weeks.

    • Patients must have given written informed consent.

    Exclusion Criteria:

    • Patients undergoing a potentially curative resection.

    • Jaundiced patients with a bilirubin value <80 μmol/L.

    • Patients not considered fit for endoscopic or percutaneous biliary stenting.

    • Patients receiving any other anti-cancer therapy.

    • History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.

    • Females who were pregnant, planning to become pregnant, or who were lactating.

    • Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study.

    • Previous G17DT treatment.

    • Haematological indicators:

    Haemoglobin (Hb) <10.0 g/dL. White cell count (WCC) <4.0×109/L. Platelets <100×109/L.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cancer Advances Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cancer Advances Inc.
    ClinicalTrials.gov Identifier:
    NCT02098239
    Other Study ID Numbers:
    • PC2
    First Posted:
    Mar 27, 2014
    Last Update Posted:
    Mar 27, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Jaundice

    Study Results

    No Results Posted as of Mar 27, 2014