drugset / Trial / NCT00415857
Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and PEG-INTRON(R)
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to find out if using the PR1 peptide vaccine (PR1) without PEG-Intron® (interferon) or in combination with interferon can reduce or eliminate disease in patients who have CML that is in cytogenetic remission after treatment with imatinib mesylate, but who still have small amounts of disease able to be noticed (detected). Researchers want to see if giving low doses of interferon together with PR1 may make the vaccine more effective. The safety of treatment in this study will also be studied.
Timeline
- Start
- 2006-12
- Primary completion
- 2013-09
- Completion
- 2013-09
Outcome
Outcome not reported
Stopped: “Vaccine sponsor ceased operations.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PR1 | Vaccine | 0.5 mg | Subcutaneous |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 0.5 ug/kg | Subcutaneous |
| Background | GM-CSF | Protein / enzyme biologic | 75 ug | Subcutaneous |
| Background | Imatinib | Small molecule | — | Oral |