Trial Search Results
Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer
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 and tolerability.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Susan Knox
Collaborator: National Cancer Institute (NCI)
Stanford Investigator(s):
Intervention(s):
- Drug: sodium selenite
- Radiation: radiation therapy
- Other: laboratory biomarker analysis
- Other: pharmacological study
- Other: questionnaire administration
Phase:
Phase 1
Eligibility
Inclusion criteria:
1. 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
2. Metastatic cancer requiring palliative radiation therapy
3. 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
4. Age ≥18 years
5. Life expectancy greater than 3 months
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or Karnofsky
performance status ≥ 80%
7. QT interval corrected using Fridericia's method (QTcF) < 460 msec (see Appendix C for
Fredericia's criteria).
8. Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria:
1. 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
2. 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
3. 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
4. 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
5. 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
6. History of myocardial infarction or unstable angina within 6 months prior to study
enrollment
7. History of stroke or transient ischemic attack within 6 months prior to study
enrollment
8. 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
9. Women who are pregnant or breastfeeding
10. Inability to comply with study and/or follow up procedures
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting