Pilot Study of Mobilization and Treatment of Disseminated Tumor Cells in Men With Metastatic Prostate Cancer

Stopped early · Phase 1

Conditions studied: Prostate Cancer

In brief

Hypothesis: Treatment with Burixafor hydrobromide will effectively mobilize metastatic prostate cancer (PCa) cells (i.e. disseminated tumor cells; DTCs) into the blood from the bone marrow. It has been demonstrated that prostate cancer cells have been mobilized out of the bone marrow of mice utilizing an anti-CXCR4 strategy; making them more susceptible to chemotherapy.

Key facts

Study ID

NCT02478125

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

3

Starts

2016-07-01

Expected to finish

2017-05-01

Last updated by the study team

2019-01-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
• Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
• Male aged 18 years and above
• Eastern cooperative group (ECOG) performance status ≤2
• Documented histologically confirmed adenocarcinoma of the prostate
• Metastatic prostate cancer to the bone as documented by positive bone scan imaging
• Patient must be eligible for chemotherapy with docetaxel
• Patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group 2 [PCWG2] criteria) and a castrate serum testosterone level (i.e. ≤ 50 mg/dL).

You may not qualify if…

• Have known allergies, hypersensitivity, or intolerance to docetaxel or dexamethasone or their excipients
• Prior pelvic radiation (e.g. external beam, brachytherapy, etc) that, in the opinion of the investigator, may lead to decreased bone marrow cellularity in a marrow sample obtained from a pelvic bone marrow biopsy
• Ongoing systemic therapy (other than a GnRH agonist/antagonist) for prostate cancer including, but not limited to:
• CYP-17 inhibitors (e.g. ketoconazole, abiraterone)
• Antiandrogens (e.g. bicalutamide, nilutamide)
• Second generation antiandrogens (e.g. enzalutamide)
• Immunotherapy (e.g. sipuleucel-T, ipilimumab)
• Chemotherapy (e.g. docetaxel, cabazitaxel)
• Prior radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium-153, etc) within the past year
• Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
• Active infection or other medical condition that would make corticosteroids (i.e. dexamethasone) use contraindicated
• Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
• Severe hepatic impairment (Child-Pugh Class C)
• History of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study)
• Have poorly controlled diabetes (HgB A1C ≥ 8%)
• Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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