Status:
COMPLETED
Safety Study of NY-ESO-1 Protein Vaccine to Treat Cancer Expressing NY-ESO-1
Lead Sponsor:
Ludwig Institute for Cancer Research
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety of repeated doses of cholesterol-bearing hydrophobized pullulan (CHP) and NY-ESO-1 protein (CHP-NY-ESO-1) and describe the NY-ESO-1 specific-humoral a...
Detailed Description
NY-ESO-1 was isolated by serological analysis of recombinant cDNA expression libraries (SEREX), using tumor mRNA and autologous serum from an esophageal cancer patient. Reverse transcription-polymeras...
Eligibility Criteria
Inclusion
- Histologically proven cancer
- Confirmed NY-ESO-1 expression
- No other effective therapy available
- 4 weeks since conventional therapy before start of the current protocol
- Performance status \< 2 (ECOG scale)
- Age \> 18
- Able and willing to give written informed consent
Exclusion
- Serious illness
- Metastatic diseases to central nervous system
- Concomitant systemic treatment with corticosteroids, anti-histaminic drugs or NSAIDs
- HIV positive
- Mental impairment that may compromise the ability to give written informed consent
- Pregnancy and breastfeeding
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00106158
Start Date
June 1 2004
End Date
December 1 2006
Last Update
November 5 2010
Active Locations (1)
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1
Dept. of Immunology, Okayama University School of Medicine and Dentistry
Okayama, Japan, 700-8558