Study of Immune Responses in Patients With Metastatic Melanoma

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Metastatic Melanoma
• Intervention / Treatment: Biological: anti-OX40

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with measurable or evaluable unresectable, stage IV metastatic melanoma. Either histologic or cytologic diagnosis is acceptable.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1 (Appendix A.)
3. Age 18 years or above.

4. 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
5. 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.
6. 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.
7. No active bleeding.
8. No clinical coagulopathy (INR <1.5, PT <16 seconds, PTT < 38 seconds).
9. Anticipated lifespan greater than 12 weeks.
10. Failed at least one prior medical therapy for metastatic melanoma.

Exclusion Criteria:

1. Active infection.
2. History of or active autoimmune disease.
3. Prior mouse monoclonal antibody treatment.
4. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
5. Need for chronic maintenance oral steroids.
6. 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.
7. Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Providence Health & Services
• Investigators: Principal Investigator: Brendan D Curti, MD, Providence Health & Services

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: August 12, 2011
• First Posted (Estimate): August 15, 2011

Study Record Updates

• Last Update Posted (Estimate): March 7, 2013
• Last Update Submitted That Met QC Criteria: March 6, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Metastatic melanoma; anti-OX40; Immunostimulatory
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: PH&S IRB 10-090