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

Providence Health & Services1 site in 1 countrySeptember 2012

ConditionsMetastatic Melanoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Metastatic Melanoma
Sponsor: Providence Health & Services
Locations: 1
Primary Endpoint: Increased number of tumor antigen specific circulating T Cells
Status: Withdrawn
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

September 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Providence Health & Services

Responsible Party

Sponsor

Eligibility Criteria

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

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.