Trial | NCT02181465  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    11
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 Started
Oct 31
1993
Primary Completion
May 31
1994
Study Completion
May 31
1994
Last Update
Jul 04
2014
Estimate

Biological G17DT

Group 1 Experimental

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

Group 2 Experimental

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

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.
No Results Posted