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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00613509
• Other study ID #: MEL11
• Status: Terminated
• Phase: Phase 2
• First received: January 16, 2008
• Last updated: April 12, 2016
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)-a2b

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Melanoma

Intervention

Biological:
• ALVAC(2) Melanoma multi-antigen therapeutic vaccine
0.5 mL, 2 cycles
• Intron A, Interferon alpha -2b
0.5 mL, 5 times per week for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen	The vaccine-induced increase of CD8 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.	Day 0 to 32 weeks post 1st vaccination	No
Other	Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen	The Vaccine-induced increase of CD4 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.	Day 0 to 32 weeks post 1st vaccination	No
Other	Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)	The immunogenicity of the treatment regimens was assessed by regulatory T-cell responses as assessed primarily by the multi-parametric intracellular cytokine staining (ICS) assay.	Day 0 to 32 weeks post 1st vaccination or treatment	No
Primary	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	No
Primary	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	No
Secondary	Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population	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.	Day 0 to 32 weeks post 1st vaccination or treatment	No
Secondary	Best Overall Objective Response in the Intent-to-treat Population	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.	Day 0 to 32 weeks post 1st vaccination or treatment	No
Secondary	Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population	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.	Day 0 to 32 weeks post 1st vaccination or treatment	No
Secondary	Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term	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.	Day 0 to 12 months post last vaccination	No

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