Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer

A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Palliative Radiation Therapy in 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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma; Recurrent Prostate Cancer; Plasmacytoma; Hormone-resistant Prostate Cancer; Adenocarcinoma of the Prostate; Stage IV Prostate Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: questionnaire administration; Other: pharmacological study; Radiation: radiation therapy; Drug: sodium selenite

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 combination of sodium selenite and palliative radiation therapy in metastatic cancer

Secondary Objectives:

• To assess the pharmacokinetics of sodium selenite
• To evaluate the anti tumor activity of sodium selenite and palliative radiation therapy when given in combination

OUTLINE:

Patients receive sodium selenite orally (PO) 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (sodium selenite and radiation therapy); Patients receive sodium selenite PO 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies; Other: pharmacological study; Correlative studies; Other Names: pharmacological studies; Radiation: radiation therapy; Undergo radiation therapy; Other Names: irradiation; radiotherapy; therapy, radiation; Drug: sodium selenite; Given PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTD defined as the maximum dose at which =< 1 of 3 to 6 subjects in a dose group experience a drug-related dose-limiting toxicity, graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v)4.0		3 weeks
Safety and tolerability of the combination using the NCI Common Toxicity Criteria v4.0 grading system for adverse events	Safety observations and measurements including adverse events, laboratory data, vital signs, and performance status will be summarized.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) profile	PK parameters will be calculated using non-compartmental and/or compartmental models and PK parameters (if possible, maximum concentration [Cmax], time to Cmax, area under the curve during the dosing interval, half-life, oral clearance) will be summarized and presented.	Week 1, day 1: at predose; 15 minutes; and at 1, 2, 4, and 24 hours; weeks 2 and 4, day 1: at predose and 1 hour
Overall biochemical response rate	Biochemical response defined as PSA decline >= 50% from baseline at 8 weeks of therapy and which has been confirmed with a second PSA at >= 3 weeks later.	Up to 11 weeks
Tumor responses within the radiation therapy field, assessed using Response Evaluation Criteria in Solid Tumors 1.1		Up to 2 years
Response rate (complete response, partial response and stable disease) within the radiation therapy field		Up to 2 years

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Susan Knox, Stanford University Hospitals and Clinics

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 3, 2014
• First Submitted That Met QC Criteria: July 3, 2014
• First Posted (Estimated): July 9, 2014

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Urogenital Neoplasms; Neoplasms by Site; Hematologic Diseases; Genital Neoplasms, Male; Prostatic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplastic Processes; Neoplasms, Plasma Cell; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Multiple Myeloma; Neoplasm Metastasis; Plasmacytoma; Physiological Effects of Drugs; Trace Elements; Micronutrients; Selenious Acid; Sodium Selenite
• Other Study ID Numbers: IRB-30587; P30CA124435 (U.S. NIH Grant/Contract); NCI-2014-01361 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); PROS0047 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No