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| Descriptive Information Fields | |||||
| Brief Title † | A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen | ||||
| Official Title † | A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen. | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study | ||||
| Primary Outcome Measure † | Toxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ] Dose level(s) of MBV eliciting body temperature increase to 38C -39.5 C. [ Time Frame: Weeks 1-5 ] [ Designated as safety issue: Yes ] |
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| Secondary Outcome Measure † | NY-ESO-1 specific immune responses [ Time Frame: Duration of Study ] [ Designated as safety issue: No ] Tumor response as defined by RECIST [ Time Frame: Duration of Study ] [ Designated as safety issue: No ] |
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| Condition † | Melanoma Sarcoma Gastrointestinal Stromal Tumor (GIST) Head and Neck Cancer Transitional Cell Carcinoma Prostate Cancer |
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| Intervention † | Biological: Mixed Bacterial Vaccine (MBV) | ||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 12 | ||||
| Start Date † | May 2007 | ||||
| Completion Date | March 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | Germany | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00623831 | ||||
| Organization ID | LUD2005-003 | ||||
| Secondary IDs †† | EudraCT:2006-002015-27 | ||||
| Study Sponsor † | Ludwig Institute for Cancer Research | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Ludwig Institute for Cancer Research | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | February 4, 2008 | ||||
| Last Updated Date | August 7, 2008 | ||||