Status:
COMPLETED
Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the maximum-tolerated dose (MTD) of sodium selenite when administered in combination with radiation therapy to subjects with metastatic cancer based on safety...
Detailed Description
Primary Objectives: * To determine the maximum tolerated dose (MTD) of sodium selenite when given in combination with palliative radiation therapy * To assess the safety and tolerability of the combi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy or prostatectomy specimen (primary site), or histological confirmation of adenocarcinoma /carcinoma in a metastatic site of disease in the setting of elevated PSA and imaging consistent with metastatic prostate cancer, or history of prostate cancer with documented metastasis, or histologically confirmed other solid tumor malignancy, multiple myeloma, or plasmacytoma with pathological confirmation of metastasis
- Metastatic cancer requiring palliative radiation therapy
- For patients with metastatic prostate cancer, PSA ≥ 2 ng/mL, except for patients who have recently started androgen deprivation therapy with PSA \< 2 ng/mL
- Age ≥18 years
- Life expectancy greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or Karnofsky performance status ≥ 80%
- QT interval corrected using Fridericia's method (QTcF) \< 460 msec (see Appendix C for Fredericia's criteria).
- Ability to understand and the willingness to sign a written informed consent document
- Exclusion criteria:
- Inadequate organ function, as evidenced by any of the following at screening:
- Absolute neutrophil count (ANC) \< 1500/µL
- Platelet count ≤ 100 x 109/L
- Serum creatinine \> 2.0 mg/dL
- Total bilirubin \> 1.5 x upper limit of normal (ULN)
- AST, and/or ALT \> 2 x ULN
- Hemoglobin \< 9 g/dL
- Men with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least 3 months after completion of the study treatment
- History of other malignancies within 5 years prior to Day 1 except for tumors that in the opinion of the investigators have a negligible risk for metastasis or death, such as (but not exclusively) adequately controlled basal cell carcinoma, squamous cell carcinoma of the skin, or early stage bladder cancer
- Current, or recent (within 4 weeks of the first treatment of this study) cytotoxic chemotherapy (eg, cisplatin, taxol) or experimental drug therapy, or planned participation in an experimental drug study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant vascular disease (eg, aortic aneurysm, aortic dissection), symptomatic peripheral vascular disease, or psychiatric illness/social situations that would limit compliance with study requirements
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- The subject is known to be positive for the human immunodeficiency virus (HIV) and is receiving antiretroviral therapies. Subjects known to be HIV positive who do not require antiretroviral therapy will be eligible if they meet other entry criteria
- Women who are pregnant or breastfeeding
- Inability to comply with study and/or follow up procedures
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02184533
Start Date
July 1 2014
End Date
May 1 2018
Last Update
May 28 2024
Active Locations (1)
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1
Stanford University, School of Medicine
Stanford, California, United States, 94305