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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2001-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10µg, Stage I-III

10µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Group Type EXPERIMENTAL

G17DT

Intervention Type DRUG

100µg, Stage I-III

100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Group Type EXPERIMENTAL

G17DT

Intervention Type DRUG

250µg, Stage I-III

250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Group Type EXPERIMENTAL

G17DT

Intervention Type DRUG

100µg, Stage IV

100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Group Type EXPERIMENTAL

G17DT

Intervention Type DRUG

250µg, Stage IV

250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Group Type EXPERIMENTAL

G17DT

Intervention Type DRUG

Interventions

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G17DT

Intervention Type DRUG

Other Intervention Names

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Gastrimmune, Insegia, PAS

Eligibility Criteria

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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

Eligible Sex

Accepts Healthy Volunteers

No