Anti-OX40, Cyclophosphamide (CTX) and Radiation in Patients With Progressive Metastatic Prostate Cancer

Sponsored by Providence Health & Services

Phase Quota
Phase 1

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.

Study Start Date: October 2010

Estimated Completion Date: October 2017

Specialties: Urology: Oncology,Prostate Oncology: Pharmacology/Therapy,Renal/Urologic Radiology: Radiotherapy (XRT)


  • Drug: Cyclophosphamide
  • Radiation: Radiation
  • Drug: Anti-OX40

Inclusion criteria

  • Patients with measurable or evaluable metastatic adenocarcinoma of the prostate. Either histologic or cytologic diagnosis is acceptable
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix A.)
  • Age 18 years old or above
  • 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
  • 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
  • At least one bone metastatic lesion amenable to radiation
  • 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
  • No active bleeding
  • No clinical coagulopathy (INR < 1.5, PT < 16 seconds, PTT < 38 seconds)
  • Anticipated lifespan greater than 12 weeks
  • Patients on LHRH agonists or bisphosphonates prior to study enrollment should continue these medications without change

Exclusion criteria

  • Active infection
  • Active autoimmune disease
  • Previous treatment with mouse monoclonal antibodies
  • Need for chronic maintenance oral steroids
  • 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
  • Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures

Study Locations And Contact Information

  • Providence Portland Medical Center, Portland Oregon
  • Providence Portland Medical Center, Portland Oregon

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