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

NCT00613509 | Terminated Phase 2 Results DMC

• 1 other identifier: MEL11
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 19

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.

Conditions

Melanoma; Cancer

Keywords

Melanoma, Cancer

Outcome Measures

Primary Outcomes (2)

• Summary of Disease Progression in Study Participants, Intent-to-treat Population

  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).

  Day 0 up to 35 weeks post 1st vaccination or treatment

• Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population

  Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol

  Day 0 - up to 35 weeks post 1st vaccination or treatment

Secondary Outcomes (4)

• Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population

  Day 0 to 32 weeks post 1st vaccination or treatment

• Best Overall Objective Response in the Intent-to-treat Population

  Day 0 to 32 weeks post 1st vaccination or treatment

• Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population

  Day 0 to 32 weeks post 1st vaccination or treatment

• Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term

  Day 0 to 12 months post last vaccination

Other Outcomes (3)

• Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen

  Day 0 to 32 weeks post 1st vaccination

• Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen

  Day 0 to 32 weeks post 1st vaccination

• Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)

  Day 0 to 32 weeks post 1st vaccination or treatment

Study Arms (2)

Study Group 1: ALVAC melanoma vaccine

EXPERIMENTAL

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

Study Group 2: Interferon alpha-2b

ACTIVE COMPARATOR

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

Interventions

ALVAC(2) Melanoma multi-antigen therapeutic vaccine BIOLOGICAL

0.5 mL, 2 cycles

Study Group 1: ALVAC melanoma vaccine

Intron A, Interferon alpha -2b BIOLOGICAL

0.5 mL, 5 times per week for 4 weeks

Also known as: Intron-A®: IFN-α2b

Study Group 2: Interferon alpha-2b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (19)

Unknown Facility

Tucson, Arizona, 85724, United States

Location

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Los Angeles, California, 90024, United States

Location

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Aurora, Colorado, 80045, United States

Location

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Atlanta, Georgia, 30322, United States

Location

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Chicago, Illinois, 60611, United States

Location

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St Louis, Missouri, 63110, United States

Location

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Omaha, Nebraska, 68198, United States

Location

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Lebanon, New Hampshire, 03756, United States

Location

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Portland, Oregon, 97213, United States

Location

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Bethlehem, Pennsylvania, 18015, United States

Location

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Pittsburgh, Pennsylvania, 15232, United States

Location

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Greenville, South Carolina, 29605, United States

Location

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Dallas, Texas, 75246, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Madison, Wisconsin, 53792, United States

Location

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Hamilton, Ontario, L8V 5C2, Canada

Location

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London, Ontario, Canada

Location

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Toronto, Ontario, M4N 3M5, Canada

Location

Unknown Facility

Montreal, Quebec, H3A 1A1, Canada

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Melanoma; Neoplasms

Interventions

Introns; Interferon alpha-2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: February 13, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 14, 2016
• Results First Posted: December 17, 2010

Record last verified: 2016-04

Locations

CA (4); US (15)