Study of Immune Responses in Patients With Metastatic Melanoma

Withdrawn before enrolling · Phase 2

Conditions studied: Metastatic Melanoma

In brief

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.

Key facts

Study ID

NCT01416844

Run by

Providence Health & Services

People needed

0

Starts

2012-09-01

Expected to finish

2012-09-01

Last updated by the study team

2013-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Providence Portland Medical Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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