Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer

NCT02184533 | Completed Phase 1 DMC FDA Drug

• 4 other identifiers: IRB-30587NCI-2014-01361PROS0047P30CA124435
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 and tolerability.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Pharmacokinetic (PK) profile

  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

  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

Study Arms (1)

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.

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

Interventions

sodium selenite DRUG

Given PO

Treatment (sodium selenite and radiation therapy)

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (sodium selenite and radiation therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (sodium selenite and radiation therapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (sodium selenite and radiation therapy)

questionnaire administration OTHER

Ancillary studies

Treatment (sodium selenite and radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Multiple Myeloma; Plasmacytoma

Interventions

Sodium Selenite; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Selenious Acid; Selenium Compounds; Inorganic Chemicals; Sodium Compounds; Therapeutics; Physical Phenomena

Study Officials

• Susan Knox

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)