Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma.

Colorectal Cancer Clinical Trial

— CC1A&B  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181465
• Other study ID #: CC1A&B
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2014
• Last updated: July 3, 2014
• Start date: October 1993
• Est. completion date: May 1994

Study information

• Verified date: July 2014
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 1994
• Est. primary completion date: May 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Cancer

Intervention

Biological:
• G17DT

Locations

Country	Name	City	State
United Kingdom	University Hospital, Queen's Medical Centre	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Advances Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse effects		Up to week 16	Yes
Secondary	Measure serum anti gastrin-17 antibodies to determine immunological response to medication		Up to week 16	Yes