A Randomized Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC in Patients With Resected MAGE-A3 Positive, Stage IV Melanoma

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country14 target enrollmentOctober 11, 2011

ConditionsMelanoma

DrugsMAGE-A3 ASCI injections without Poly IC:LC MAGE-A3 ASCI injections with Poly IC:LC

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Melanoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Enrollment: 14
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events Related to Study Treatment
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The overall purpose of this research study is to find a better way to treat melanoma.

The goals of this study are:

To measure the side effects of and find out how well patients tolerate the recMAGE-A3 + AS15 ASCI (MAGE-A3 ASCI) treatment with or without the Poly IC:LC
To see how well the patient's immune system responds to the MAGE-A3 ASCI treatment with or without the Poly IC:LC
To measure the rate of return of the patient's tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC
To measure the rate of return of the patient's tumor in two groups of patients: one group positive for the gene signature, and the other group not positive for the gene signature in their tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC.

Detailed Description

In the first year, participants may receive up to 8 injections given in the following order: 1. 5 ASCI injections with or without Poly IC:LC with a 3-week interval between each. 2. 3 ASCI injections with or without Poly IC:LC with a 3-month interval between each. During years 2 through 3, participants may receive up to 5 ASCI injections with or without Poly IC:LC given in the following order: 3. During year 2, ASCI injections with or without Poly IC:LC will be given every 3 months for a total of up to 3 injections. 4. During year 3, ASCI injections with or without Poly IC:LC will continue to be given every 3 months for a total of up to 2 more injections.

Registry

clinicaltrials.gov

Start Date

October 11, 2011

End Date

July 18, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent for the study will be obtained prior to the performance of MAGE-A3 expression screening on resected tumor tissue or any other protocol-specific procedure.
•Male or female patient with histologically proven and completely resected stage IV cutaneous or mucosal melanoma. In terms of the American Joint Committee on Cancer (AJCC) classification \[AJCC, 2009\], this means that patients with resected M1a-b-c (stage IV) disease may be enrolled.
•The patient must have been surgically rendered free of disease no more than 12 weeks before the randomization.
•Patient is equal to or greater than 18 years old at the time of signing the informed consent form.
•The patient's tumor shows expression of the MAGE-A3 gene, as determined by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) analysis on paraffin imbedded tumor tissue (FFPE). In all patients in whom it can be obtained, a frozen portion of the resected tumor will be analyzed for gene profiling.
•The patient has fully recovered from surgery.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of randomization.
•The patient must have adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria: Absolute neutrophil count (ANC) equal to or greater than 1.5 x 10\^9/L, Platelet count equal to or greater than 75 x 10\^9/L, Serum creatinine equal to or less than 1.5 times the Upper Limit of Normal (ULN), Total bilirubin equal to or less than 1.5 times the ULN, Transaminase (ALT - AST) equal to or less than 2.5 times the ULN
•If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to randomization, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series.
•Men must also agree to use an adequate method of contraception.

Exclusion Criteria

•The patient has an ocular melanoma.
•The patient has in-transit metastases.
•The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the metastasectomy that qualifies the patient for inclusion in the present trial.
•One prior systemic treatment with an immunomodulator (i.e., interferon, vaccine and/or anti-CTLA-4) after a previous surgery is permitted, provided that the last dose has been administered at least 45 days before randomization in the present trial.
•Previous radiotherapy is permitted, provided that the treatment has been completed before the surgery that qualifies the patient for participation in the present trial.
•The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents. The use of prednisone, or equivalent, at a dose of \< 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids is permitted.
•Use of any investigational or non-registered product (drug or vaccine) other than the study treatment within 30 days preceding the randomization or planned use during the study period.
•The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
•The patient has a family history of congenital or hereditary immunodeficiency.
•The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.

Outcomes

Primary Outcomes

Number of Participants With Adverse Events Related to Study Treatment

Time Frame: Beginning of Treatment to End of Follow Up - up to 5 years per participant

Number of participants with adverse events after receiving one dose of recMAGE-A3 + AS15 ASCI or recMAGEA3 + AS15 ASCI in combination with Poly IC:LC

Secondary Outcomes

Immunogenicity Per Treatment Arm(Beginning of Treatment to End of Follow Up - up to 5 years per participant)
Percentage of Participants With Relapse-Free Survival (RFS)(Beginning of Treatment to End of Follow Up - up to 2 years per participant)
Median Overall Survival (OS)(At 5 years)