Study of Immune Responses in Patients With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01416844
Recruitment Status : Withdrawn (Change in the development plan for the anti-OX40 antibody.)
First Posted : August 15, 2011
Last Update Posted : March 7, 2013
Information provided by (Responsible Party):
Providence Health & Services

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.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Biological: anti-OX40 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Exploratory Study of Immune Responses in Patients With Metastatic Melanoma Treated With Mouse Monoclonal Anti-OX40
Study Start Date : September 2012
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. Increased number of tumor antigen specific circulating T Cells [ Time Frame: Screening (baseline) and Day 15 ]
    T Cells will be harvested by apheresis at baseline and Day 15 following anti-OX40 administration.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01416844

United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
Principal Investigator: Brendan D Curti, MD Providence Health & Services

Responsible Party: Providence Health & Services Identifier: NCT01416844     History of Changes
Other Study ID Numbers: PH&S IRB 10-090
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Providence Health & Services:
Metastatic melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas