Clinical trial NCT00613509: Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
Official title: Phase II Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma
Cancer
Keywords: Melanoma, Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria :

* A pathologically confirmed diagnosis of malignant melanoma with at least one measurable metastatic lesion with a minimum lesion size of 20 mm, based on radiological assessment (or 10 mm if assessed by spiral computed tomography \[CT\] scan ) as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Stages IIIc, IVa, or IVb only, according to the American Joint Committee on Cancer (AJCC) staging system for melanoma). Cutaneous metastasis (assessed by physical examination) must be at least 10 mm. CT scan or magnetic resonance imaging (MRI) is required to rule out brain metastases.
* Patients who received prior treatment for their metastatic disease must have objective evidence of disease progression.
* Aged ≥ 18 years on the day of inclusion
* IRB-approved informed consent form signed
* Able to attend all scheduled visits and to comply with all trial procedures
* For a woman, inability to bear a child or negative serum pregnancy test
* For a woman of child-bearing potential, using an effective method of contraception or abstinence during the study and at least 4 weeks after the last study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
* Adequate hematologic, hepatic, and renal function (at pre-defined laboratory values).
* Fully recovered from surgery, if applicable.

Exclusion Criteria :

* Receipt of two or more previous therapies for metastatic melanoma.
* Receipt of chemotherapy or another therapy for metastatic melanoma within the last four weeks
* Receipt of adjuvant interferon therapy within the last six months
* Concurrent receipt of radiotherapy for the metastatic disease, unless for palliative purposes
* Participation in another clinical trial within the four weeks preceding the first trial treatment
* Planned participation in another clinical trial during the present trial period
* Known Human Immunodeficiency Virus (HIV) infection or hepatitis B (Ag HBs) or hepatitis C seropositivity
* Presence of active autoimmune disease (excluding vitiligo)
* Systemic hypersensitivity to bovine products or to any of the vaccine components, including egg products or Neomycin (used to prepare the vaccine), or history of a life-threatening reaction to granulocyte-macrophage colony stimulating factor (GM-CSF) or interferon (IFN)-α2b
* Current alcohol or drug addiction that may interfere with the ability to comply with trial procedures
* Significant co-morbid medical conditions, including pre-existing renal disease, cirrhosis, or major depression, which in the estimation of the investigator would preclude safe participation in the study or the accurate interpretation of data.
* A calculated glomerular filtration rate (GFR) \<60 mL/min (based on the Cockroft-Gault formula).
* Previous receipt of a modified canarypox virus (ALVAC)-based vaccine.

Primary outcomes:
measure: Summary of Disease Progression in Study Participants, Intent-to-treat Population
timeFrame: Day 0 up to 35 weeks post 1st vaccination or treatment
measure: Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population
timeFrame: Day 0 - up to 35 weeks post 1st vaccination or treatment
Secondary outcomes:
measure: Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
timeFrame: Day 0 to 32 weeks post 1st vaccination or treatment
measure: Best Overall Objective Response in the Intent-to-treat Population
timeFrame: Day 0 to 32 weeks post 1st vaccination or treatment
measure: Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population
timeFrame: Day 0 to 32 weeks post 1st vaccination or treatment
measure: Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
timeFrame: Day 0 to 12 months post last vaccination
Other outcomes:
measure: Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen
timeFrame: Day 0 to 32 weeks post 1st vaccination
measure: Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen
timeFrame: Day 0 to 32 weeks post 1st vaccination
measure: Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)
timeFrame: Day 0 to 32 weeks post 1st vaccination or treatment
Locations:
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: St Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Lebanon
country: United States
state: New Hampshire
city: Portland
country: United States
state: Oregon
city: Bethlehem
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Madison
country: United States
state: Wisconsin
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: