Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
This study has been terminated.
(No safety concerns, the study was terminated due to slow enrollment. All enrolled patients were followed per protocol.)
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00613509
First received: January 16, 2008
Last updated: November 22, 2010
Last verified: November 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Cancer |
Biological: ALVAC(2) Melanoma multi-antigen therapeutic vaccine Biological: Intron A, Interferon alpha -2b |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Summary of Disease Progression in Study Participants, Intent-to-treat Population [ Time Frame: Day 0 up to 35 weeks post 1st vaccination or treatment ] [ Designated as safety issue: No ]Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination).
- Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population [ Time Frame: Day 0 - up to 35 weeks post 1st vaccination or treatment ] [ Designated as safety issue: No ]Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol
Secondary Outcome Measures:
- Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population [ Time Frame: Day 0 to 32 weeks post 1st vaccination or treatment ] [ Designated as safety issue: No ]Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
- Best Overall Objective Response in the Intent-to-treat Population [ Time Frame: Day 0 to 32 weeks post 1st vaccination or treatment ] [ Designated as safety issue: No ]Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
- Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population [ Time Frame: Day 0 to 32 weeks post 1st vaccination or treatment ] [ Designated as safety issue: No ]Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
- Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term [ Time Frame: Day 0 to 12 months post last vaccination ] [ Designated as safety issue: No ]
Common Terminology Criteria for Adverse Events (CTCAE) definitions:
Grade 3 is a severe adverse event; Grade 4 is a life-threatening or disabling adverse event.
| Enrollment: | 23 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Study Group 1: ALVAC melanoma vaccine
Participants will receive a multi-antigen of modified canarypox virus (ALVAC[2]) melanoma vaccine and granulocyte macrophage colony stimulating factor (GM-CSF) every 3 weeks, followed by 4 weeks of high-dose interferon alpha-2b 5 times per week.
|
Biological: ALVAC(2) Melanoma multi-antigen therapeutic vaccine
0.5 mL, 2 cycles
|
|
Active Comparator: Study Group 2: Interferon alpha-2b
Participants on 4 weeks of high-dose interferon alpha-2b 5 times per week. Participants who showed disease progression after Cycle 1 will be permitted to cross over to Group 1 treatment.
|
Biological: Intron A, Interferon alpha -2b
0.5 mL, 5 times per week for 4 weeks
Other Name: Intron-A®: IFN-α2b
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613509
Locations
| United States, Arizona | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Los Angeles, California, United States, 90024 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60611 | |
| United States, Missouri | |
| St Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Hampshire | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Texas | |
| Dallas, Texas, United States, 75246 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Canada, Ontario | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| London, Ontario, Canada | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H3A 1A1 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Monitor, Sanofi Pasteur, Inc |
| ClinicalTrials.gov Identifier: | NCT00613509 History of Changes |
| Other Study ID Numbers: | MEL11 |
| Study First Received: | January 16, 2008 |
| Results First Received: | September 14, 2010 |
| Last Updated: | November 22, 2010 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Sanofi:
|
Melanoma, Cancer |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Reaferon Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Adjuvants, Immunologic Alcohol Deterrents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013