Trials / Terminated
TerminatedNCT00613509
Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
Phase II Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary objective: To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment. Secondary objectives: Safety: To describe the safety profile in both treatment groups. Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response.
Detailed description
Eligible participants will be randomized to receive either a vaccine treatment consisting of a series of multi-antigen melanoma vaccine and GM-CSF injections, followed by high-dose IFN-α2b or only the high-dose IFN-α2b.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALVAC(2) Melanoma multi-antigen therapeutic vaccine | 0.5 mL, 2 cycles |
| BIOLOGICAL | Intron A, Interferon alpha -2b | 0.5 mL, 5 times per week for 4 weeks |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2010-04-01
- Completion
- 2010-06-01
- First posted
- 2008-02-13
- Last updated
- 2016-04-14
- Results posted
- 2010-12-17
Locations
19 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00613509. Inclusion in this directory is not an endorsement.