Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma

NCT ID: NCT00613509

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-06-30

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.

Conditions

Melanoma; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ALVAC(2) Melanoma multi-antigen therapeutic vaccine

Intervention Type: BIOLOGICAL

0.5 mL, 2 cycles

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.

Group Type: ACTIVE_COMPARATOR

Intron A, Interferon alpha -2b

Intervention Type: BIOLOGICAL

0.5 mL, 5 times per week for 4 weeks

Interventions

ALVAC(2) Melanoma multi-antigen therapeutic vaccine

0.5 mL, 2 cycles

Intervention Type: BIOLOGICAL

Intron A, Interferon alpha -2b

0.5 mL, 5 times per week for 4 weeks

Intervention Type: BIOLOGICAL

Other Intervention Names

Intron-A®: 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Tucson, Arizona, United States

Los Angeles, California, United States

Aurora, Colorado, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Lebanon, New Hampshire, United States

Portland, Oregon, United States

Bethlehem, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Greenville, South Carolina, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Madison, Wisconsin, United States

Hamilton, Ontario, Canada

London, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Countries

United States; Canada

Related Links

http://www.sanofipasteur.com

Related Info

http://www.cancervaccines.com

Related Info

Other Identifiers

MEL11

Identifier Type: -

Identifier Source: org_study_id