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

NCT ID: NCT02181465

Last Updated: 2014-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-10-31
• Study Completion Date: 1994-05-31

Brief 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

One injection of G17DT followed by up to three booster injections depending on antibody response over 16 week period

Group Type: EXPERIMENTAL

G17DT

Intervention Type: BIOLOGICAL

Group 2

Three injections of G17DT with option of one booster after 16 weeks

Group Type: EXPERIMENTAL

G17DT

Intervention Type: BIOLOGICAL

Interventions

G17DT

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Advances Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital, Queen's Medical Centre

Nottingham, Nottinghamshire, United Kingdom

Countries

United Kingdom

Other Identifiers

CC1A&B

Identifier Type: -

Identifier Source: org_study_id