Trial record 1 of 177054 for:    ALL
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Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cancer Advances Inc.
ClinicalTrials.gov Identifier:
NCT02098239
First received: March 25, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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 Intervention Phase
Jaundice
Pancreatic Cancer
Drug: G17DT
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Cancer Advances Inc.:

Primary Outcome Measures:
  • Pharmacodynamic [ Time Frame: Weeks 0, 1,3,4,6,8,12, 16+ ] [ Designated as safety issue: No ]
    Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.

  • Patient Survival [ Time Frame: Up to week 139 ] [ Designated as safety issue: No ]
    The vital status of patients was monitored throughout the study and was followed until death or the end of the study.


Secondary Outcome Measures:
  • Injection Tolerability [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
    Tolerability was assessed by injection site during first 16 weeks after the first injection.


Enrollment: 41
Study Start Date: August 1999
Estimated Study Completion Date: May 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting.
Drug: G17DT
Other Name: 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 Name: Polyclonal Antibody Stimulator (PAS)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT02098239     History of Changes
Other Study ID Numbers: PC2
Study First Received: March 25, 2014
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014