Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

An Open, Dose-ranging, Multicenter Study to Determine the Antibody Response to G17DT and Its Safety and Tolerability in the Treatment of Patients With Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521649
• Other study ID #: GC2
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2015
• Last updated: August 10, 2015
• Start date: September 1998
• Est. completion date: January 2001

Study information

• Verified date: August 2015
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Stage I-III Criteria-

• Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.

• Absence of metastatic disease evident from:

• physical examination

• the most recent chest X-ray

• abdominal CT or ultrasound scan

• Life expectancy of at least 3 months

• WHO performance status of 0 to 1

• Written informed consent given

Stage IV Criteria-

• Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases

• Life expectancy of at least 3 months

• WHO performance status of 0 to 2

• Written informed consent given

Exclusion Criteria:

• History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection

• Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies

• Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids

• Females who were pregnant, planning to become pregnant or lactating

• Patients who were 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 <10.0g/dl

• White blood cell count <4.0 x 109/l

• Platelets <100 x 109/l

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• G17DT

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Cancer Advances Inc.	Clinical Project Services, MPS Research Unit

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurable Antibody Titer		Up to Week 12	No
Secondary	Overall Survival from date of randomization to death or end of study	Patients were scheduled to attend follow-up visits every four weeks after completion of the 12-week core period of the study and to continue until the patient was discharged from the study or declined further follow-up.	Up to Last Patient Last Visit, January 2001	No
Secondary	Injection Site Reaction	A physical examination for the presence of an abcess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12.	Through Week 12	Yes