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Sponsored by: |
Ludwig Institute for Cancer Research |
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Information provided by: | Ludwig Institute for Cancer Research |
ClinicalTrials.gov Identifier: | NCT00623831 |
This is a phase 1, open label, multiple dosing, single arm study. Each patient will be enrolled to receive MBV subcutaneously at the starting dose of 250 EU (1 µL) twice weekly. In the absence of a dose-limiting toxicity (DLT, the MBV dose will be escalated in each patient to the MBV dose level that elicits a body temperature of 38C -39.5C or up to the maximum dose level 8. Once the desired pyrogenic effect is reached, patients will then be given MBV twice weekly for 4 doses at the pyrogenic dose level. For patients not achieving the desired pyrogenic effect at dose level 8, no additional MBV will be administered.Vaccination will be administered twice weekly on Monday and Thursday of each week.
During each vaccination clinic visit, patients will be observed up to 6 hours post vaccination and vital signs will be measured hourly. At baseline, and throughout the study period, patients will be assessed for NY-ESO-1 specific humoral and cellular immunity, chemistry, hematology and cytokine analysis for IL-1, IL-6, IFNgamma, and TNF-alpha. Toxicity assessments will be made throughout the study.
Condition | Intervention | Phase |
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Melanoma Sarcoma Gastrointestinal Stromal Tumor (GIST) Head and Neck Cancer Transitional Cell Carcinoma Prostate Cancer |
Biological: Mixed Bacterial Vaccine (MBV) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen. |
Estimated Enrollment: | 12 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Declined, intolerated or completed standard therapy defined as following for each tumor entity:
Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:
Exclusion Criteria:
Contact: Antje Neumann | 069 7601-4161 | neumann.antje@khnw.de |
Germany | |
Krankenhaus Nordwest | Recruiting |
Frankfurt, Germany | |
Contact: Antje Neumann 069 7601 4161 neumann.antje@khnw.de | |
Principal Investigator: Elke Jaeger, Prof. Dr. med | |
Sub-Investigator: Eckhart Weidmann, MD | |
Sub-Investigator: Armin Bender, MD |
Principal Investigator: | Elke Jaeger, Prof.Dr. med | Krankenhaus Nordwest |
Responsible Party: | Ludwig Institute for Cancer Research ( Ralph Venhaus, MD, Head of Clinical and Regulatory Affairs ) |
Study ID Numbers: | LUD2005-003, EudraCT:2006-002015-27 |
Study First Received: | February 4, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00623831 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
MBV Mixed Bacterial Vaccine NY-ESO-1 |
Genital Neoplasms, Male Prostatic Diseases Gastrointestinal Diseases Malignant mesenchymal tumor Urogenital Neoplasms Carcinoma, Transitional Cell Soft tissue sarcomas Melanoma Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Digestive System Neoplasms Genital Diseases, Male |
Transitional cell carcinoma Neuroendocrine Tumors Carcinoma Neuroectodermal Tumors Digestive System Diseases Head and Neck Neoplasms Sarcoma Gastrointestinal Neoplasms Nevus Gastrointestinal Stromal Tumors Prostatic Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |