Trials / Completed
CompletedNCT00291473
Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers
Safety and Immunogenicity of Cholesterol-Bearing Hydrophobized Pullulan HER2 Protein 146 (CHP-HER2) and NY-ESO-1 Protein (CHP-NY-ESO-1) in Combination With OK-432 in HER2- and/or NY-ESO-1-Expressing Cancers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- Sponsor
- Ludwig Institute for Cancer Research · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Mixed cancer vaccines, CHP-HER2 protein and CHP-NY-ESO-1 protein, are to be studied to evaluate the safety and immune responses in patients who are positive either or both antigens. Nine patients will be enrolled, who are refractory to standard therapies for cancer or at high risk to relapse. CHP-HER2 and CHP-NY-ESO-1 are subcutaneously given on bimonthly basis, together with OK-432(Picibanil) as an immunoadjuvant. Six doses will be given. Toxicity profiles will be monitored, and antigen specific humoral anad T cell responses will be described.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHP-HER2, CHP-NY-ESO-1 |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2006-02-14
- Last updated
- 2009-03-03
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00291473. Inclusion in this directory is not an endorsement.