Study of Immune Responses in Patients With Metastatic Melanoma

This study has been withdrawn prior to enrollment.
(Change in the development plan for the anti-OX40 antibody.)
Sponsor:
Information provided by (Responsible Party):
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT01416844
First received: August 12, 2011
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Metastatic Melanoma
Biological: anti-OX40
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Increased number of tumor antigen specific circulating T Cells [ Time Frame: Screening (baseline) and Day 15 ] [ Designated as safety issue: No ]
    T Cells will be harvested by apheresis at baseline and Day 15 following anti-OX40 administration.


Enrollment: 0
Study Start Date: September 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416844

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

No publications provided

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01416844     History of Changes
Other Study ID Numbers: PH&S IRB 10-090
Study First Received: August 12, 2011
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Providence Health & Services:
Metastatic melanoma
anti-OX40
Immunostimulatory

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

ClinicalTrials.gov processed this record on August 18, 2014