CClinicalTrials.gg
CompletedNCT02184533Updated May 28, 2024

Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer

A Phase 1 interventional study of sodium selenite and radiation therapy in Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Stanford University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 and tolerability.

Read the 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.

02

Conditions studied

  • Adenocarcinoma of the Prostate
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
  • Multiple Myeloma
  • Plasmacytoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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.

    Drug: sodium selenite · Radiation: radiation therapy · Other: laboratory biomarker analysis · Other: pharmacological study · Other: questionnaire administration

Interventions

  • Drugsodium selenite

    Given PO

  • Radiationradiation therapy

    Undergo radiation therapy

    Also known as: irradiation, radiotherapy, therapy, radiation

  • Otherlaboratory biomarker analysis

    Correlative studies

  • Otherpharmacological study

    Correlative studies

    Also known as: pharmacological studies

  • Otherquestionnaire administration

    Ancillary studies

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 weeks

  2. 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.

    Time frame: Up to 2 years

Secondary outcomes

  1. 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.

    Time frame: 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

  2. 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.

    Time frame: Up to 11 weeks

  3. Tumor responses within the radiation therapy field, assessed using Response Evaluation Criteria in Solid Tumors 1.1

    Time frame: Up to 2 years

  4. Response rate (complete response, partial response and stable disease) within the radiation therapy field

    Time frame: Up to 2 years

06

Study locations

1 site
  • Stanford University, School of Medicine
    Stanford, California 94305, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02184533
Lead sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 9, 2014
Start date
Jul 2014
Primary completion
May 2018
Completion
May 2018
Last update
May 28, 2024

Study contacts

Susan Knox
principal investigator · Stanford University Hospitals and Clinics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion