Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma. (CC1A&B)

Phase II, Open Label, Single Center, Two Arm Study Study to Assess the Safety, Tolerance and Efficacy of a 2 mg Dose of G17DT Via Intramuscular Injection in Patients With Advanced Metastatic Colorectal Adenocarcinoma.

Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Biological: G17DT

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom
      • University Hospital, Queen's Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically verified adenocarcinoma of the colon or rectum
• Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
• measurable/ evaluable lesions
• Life expectancy > 3 months
• Karnofsky index > 50% or WHO performance rating of 0-2

• Biochemical markers:

  • renal function < 25% above upper limit of normal range (creatinine, 140 imol/1 unless malignant involvement proven)
  • liver function < 25% above upper limit of normal range (bilirubin ~25 mcmol/1 unless malignant involvement proven)

• Haematological status:

  • haemoglobin, 11 g/ dl
  • WBC, 4 X 109/1
  • platelets, 100 x 109/l
• Written consent

Exclusion Criteria:

• Other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1
• H 2 receptor antagonist or proton pump inhibitor therapy
• Previous gastric surgery (including vagotomy)
• Active uncontrolled infection
• Autoimmune disorders
• Anticancer treatment within the last three months unless progression of the disease occurred in the interim
• Women of child-bearing age
• Patient is a poor medical risk because of non-malignant systemic disease
• Previous radiotherapy to all measurable or evaluable lesions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; One injection of G17DT followed by up to three booster injections depending on antibody response over 16 week period	Biological: G17DT
Experimental: Group 2; Three injections of G17DT with option of one booster after 16 weeks	Biological: G17DT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse effects	Up to week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure serum anti gastrin-17 antibodies to determine immunological response to medication	Up to week 16

Collaborators and Investigators

• Sponsor: Cancer Advances Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 1993
• Primary Completion (Actual): May 1, 1994
• Study Completion (Actual): May 1, 1994

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 3, 2014
• First Posted (Estimate): July 4, 2014

Study Record Updates

• Last Update Posted (Estimate): July 4, 2014
• Last Update Submitted That Met QC Criteria: July 3, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: CC1A&B