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Study ID
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PH&S IRB 10-088
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Investigator
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Brendan D Curti, MD, Providence Health & Services
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Title
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Anti-OX40, Cyclophosphamide (CTX) and Radiation in Patients With Progressive Metastatic Prostate Cancer
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Conditions
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Metastatic Prostate Cancer
Cancer of the Prostate
Prostate Cancer
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Interventions
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Drug: Anti-OX40
Radiation: Radiation
Drug: Cyclophosphamide
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Phase
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Phase 1/Phase 2
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Purpose
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This clinical trial will examine a novel combination of anti-OX40 to induce proliferation of
memory and effector T cells in conjunction with cyclophosphamide (CTX) and radiation to
induce tumor antigen release with the overall goal of promoting an immune response against
prostate cancer.
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Eligibility
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Ages Eligible: 18 Years
Genders Eligible:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
1. Patients with measurable or evaluable metastatic adenocarcinoma of the prostate.
Either histologic or cytologic diagnosis is acceptable
2. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix A.)
3. Age 18 years old or above
4. Laboratory values (performed within 28 days prior to enrollment) as follows:
- WBC ≥ 2000/microlitre
- Serum creatinine < 1.5 X upper limit of laboratory normal
- Hgb > 8g/dl (patients may be transfused to reach this level)
- Platelets > 100,000 cells/mm3
- Total bilirubin < 1.5 X upper limit of laboratory normal, unless due to
Gilbert's disease
- AST (SGOT) and ALT (SGPT) < 2.5 X upper limit of laboratory normal
- Alkaline phosphatase < 2.5 X upper limit of laboratory normal (If alkaline
phosphatase > 2.5 X upper limit of laboratory normal due to bone metastases,
then patient is eligible.)
- HIV 1 and 2 antibody Negative
- Hepatitis B surface antigen Negative
- Hepatitis C antibody Negative
- PSA > 2 ng/ml
- Testosterone < 50 ng/ml
5. Confirmed radiographic and/or PSA progression (using PCWG2 definitions) after at
least one androgen ablation regimen and docetaxel.Patients who refuse docetaxel
chemotherapy or who are not candidates for docetaxel are eligible to enroll.
6. At least one bone metastatic lesion amenable to radiation
7. Ability to give informed consent and comply with the protocol. Patients with a
history of psychiatric illness must be judged able to understand the investigational
nature of the study and the risks associated with the therapy
8. No active bleeding
9. No clinical coagulopathy (INR < 1.5, PT < 16 seconds, PTT < 38 seconds)
10. Anticipated lifespan greater than 12 weeks
11. Patients on LHRH agonists or bisphosphonates prior to study enrollment should
continue these medications without change
Exclusion Criteria:
1. Active infection.
2. Active autoimmune disease.
3. Previous treatment with mouse monoclonal antibodies
4. Need for chronic maintenance oral steroids.
5. Active brain metastatic disease. Patients with treated brain metastases with
surgery, gamma-knife radiosurgery or radiation and stable for at least 4 weeks and
off steroids are eligible.
6. Any medical or psychiatric condition that in the opinion of the PI would preclude
compliance with study procedures.
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Study Location
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N/A
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Contact
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Scot Lary, RN, BSN, MPA
503 215-2604
john.lary@providence.org
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Information obtained from ClinicalTrials.gov, on
5/25/2013. For additional information about
this and other clinical trials,
visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier:
NCT01303705
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