Study of Immune Responses in Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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In this study, anti-OX40 will be given to patients with melanoma to find out how the immune system responds to treatment with anti-OX40. It is hoped that this treatment will cause an immune response against melanoma resulting in tumor regression, but this is not known at this time. Anti-OX40 is a large protein that can help immune cells that fight bacteria, viruses and cancer cells.

Official Title
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Phase II Exploratory Study of Immune Responses in Patients With Metastatic Melanoma Treated With Mouse Monoclonal Anti-OX40

Conditions
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Metastatic Melanoma

Intervention / Treatment
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* Biological: anti-OX40


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with measurable or evaluable unresectable, stage IV metastatic melanoma. Either histologic or cytologic diagnosis is acceptable. Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1 (Appendix A.) Age 18 years or above. Laboratory values (performed within 28 days prior to enrollment) as follows: WBC ≥2000/microliter Absolute lymphocyte count >300/mm3 Serum creatinine <1.5 X upper limit of laboratory normal Hgb >8g/dl (patients may be transfused to reach this level) Hct > 24% Platelets >100,000 cells/mm3 Total bilirubin <1.5 X upper limit of laboratory normal, unless due to Gilbert's disease AST (SGOT)/ALT (SGPT) <2.5 X upper limit of laboratory normal Alkaline phosphatase <2.5 X upper limit of laboratory normal HIV Negative Hepatitis B surface antigen Negative Hepatitis C antibody Negative Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment. This exclusion is required due to the unknown toxicities that anti-OX40 may have on the forming fetus, spermatogenesis or the nursing child. Also, because pregnancy may impair immune function it may limit the treatment efficacy. Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy. No active bleeding. No clinical coagulopathy (INR <1.5, PT <16 seconds, PTT < 38 seconds). Anticipated lifespan greater than 12 weeks. Failed at least one prior medical therapy for metastatic melanoma. Exclusion Criteria: Active infection. History of or active autoimmune disease. Prior mouse monoclonal antibody treatment. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus. Need for chronic maintenance oral steroids. Active brain metastatic disease. Treated brain metastases with surgery, gamma-knife radiosurgery and/or whole brain radiation and stable for at least 4 weeks and off steroids are eligible. Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: anti-OX40|Patients with metastatic melanoma will be given 0.4 mg/kg anti-OX40 on days 1, 3 and 5 of a single treatment cycle.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased number of tumor antigen specific circulating T Cells | T Cells will be harvested by apheresis at baseline and Day 15 following anti-OX40 administration. | Screening (baseline) and Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic melanoma, anti-OX40, Immunostimulatory