CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
Mixed bacterial vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00623831
NCT00623831Phase 1Completed
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A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen.

Ludwig Institute for Cancer Research·interventional·Posted Feb 26, 2008·Updated Oct 25, 2022

In Brief

A Phase 1 clinical trial evaluating Mixed bacterial vaccine for Melanoma and 8 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed Summary

This was a phase 1, open-label, multiple dose, single-arm study. The mixed bacteria vaccine (MBV) was administered at a starting dose of 250 EU (1 µL) and escalated in each subject to a dose inducing the desired pyrogenic effect, defined as a body temperature of 38°C to 39.5°C. The primary objective was to determine the safety profile of MBV in subjects with malignant tumors that expressed the NY-ESO-1 antigen and to identify the dose that induced the desired pyrogenic effect. Secondary objectives were to evaluate the immunological effects and tumor response of subjects following vaccination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma, Sarcoma, Gastrointestinal Stromal Tumor (GIST), Head and Neck Cancer, Transitional Cell Carcinoma, Prostate Cancer, Ovarian Carcinoma, Esophageal Cancer, Breast Cancer
CountriesGermany
CollaboratorsKrankenhaus Nordwest

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 26, 2008
Enrollment StartMay 1, 2007
Primary CompletionMay 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 18.3 years ago

Interventions

Mixed bacterial vaccinebiological

MBV was administered twice weekly by subcutaneous injection in Cohort 1 and by intralesional (preferred) or subcutaneous (if intralesional not possible) injection in Cohort 2. In Cohort 1, the MBV starting dose was 250 EU (dose level 1) with possible intrasubject escalations up to 547,000 EU (dose level 8). In Cohort 2, all subjects received MBV at a fixed dose of 60,800 EU (dose level 6).