Adenocarcinoma of the ProstatePhase 1NCT02184533
Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer
A Phase 1 study testing sodium selenite, radiation therapy and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by Stanford University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer
- What is being tested?
- sodium selenite, radiation therapy and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: 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.
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.
- Conditions
- Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer, Multiple Myeloma, Plasmacytoma
- Being tested
- sodium selenite, radiation therapy, laboratory biomarker analysis, pharmacological study, questionnaire administration
- Medical subject headings
- Prostatic Neoplasms, Multiple Myeloma, Plasmacytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium seleniteDrug
Given PO
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiation therapy
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (sodium selenite and radiation therapy) | Experimental | 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. Receives: Drug: sodium selenite; Radiation: radiation therapy; Other: laboratory biomarker analysis; Other: pharmacological study; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Up to 2 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: Up to 11 weeks
Tumor responses within the radiation therapy field, assessed using Response Evaluation Criteria in Solid Tumors 1.1
Measured: Up to 2 years
Response rate (complete response, partial response and stable disease) within the radiation therapy field
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan Knox, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184533
- Sponsor's protocol ID
- IRB-30587
- Other IDs
- NCI-2014-01361, PROS0047, P30CA124435
- Status last verified
- May 2024
- First submitted
- 3 Jul 2014
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Palliative Radiation Therapy in Patients With Metastatic Cancer
- ClinicalTrials.gov ID
- NCT02184533
- Acronym / sponsor ID
- IRB-30587
- Conditions
- Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer, Multiple Myeloma, Plasmacytoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (sodium selenite and radiation therapy) | Experimental | Drug: sodium selenite, Radiation: radiation therapy, Other: laboratory biomarker analysis, Other: pharmacological study, Other: questionnaire administrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- Inadequate organ function, as evidenced by any of the following at screening:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium seleniteGiven PO | Drug | Treatment (sodium selenite and radiation therapy) |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiation therapy | Radiation | Treatment (sodium selenite and radiation therapy) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (sodium selenite and radiation therapy) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (sodium selenite and radiation therapy) |
| questionnaire administrationAncillary studies | Other | Treatment (sodium selenite and radiation therapy) |
Primary outcome
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
Safety and tolerability of the combination using the NCI Common Toxicity Criteria v4.0 grading system for adverse events
Time frame: Up to 2 years
Safety observations and measurements including adverse events, laboratory data, vital signs, and performance status will be summarized.
4 secondary outcomes
Pharmacokinetic (PK) profile
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
Overall biochemical response rate
Time frame: Up to 11 weeks
Tumor responses within the radiation therapy field, assessed using Response Evaluation Criteria in Solid Tumors 1.1
Time frame: Up to 2 years
Response rate (complete response, partial response and stable disease) within the radiation therapy field
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Knox principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sodium selenite, radiation therapy and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.