Status:
WITHDRAWN
Study of Immune Responses in Patients With Metastatic Melanoma
Lead Sponsor:
Providence Health & Services
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01416844
Start Date
September 1 2012
End Date
September 1 2012
Last Update
March 7 2013
Active Locations (1)
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1
Providence Portland Medical Center
Portland, Oregon, United States, 97213