- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02683148
DHEA in Synovial Sarcoma Patients
September 4, 2019 updated by: Washington University School of Medicine
A Phase I/II Clinical Trial of Dose-Escalating DHEA in Synovial Sarcoma Patients
DHEA is a natural allosteric inhibitor of glucose-6-phosphate dehydrogenase (G6PD).
G6PD is a key regulatory enzyme for the survival of synovial sarcoma.
The investigators postulate that they can inhibit the production of NADPH in synovial sarcoma and cause cell death by using a naturally occurring G6PD inhibitor.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of histologically or cytologically confirmed metastatic or non-resectable synovial sarcoma.
- Failed at least one line of chemotherapy. Neoadjuvant and adjuvant chemotherapy count as a prior line of therapy.
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
- At least 16 years of age.
- ECOG performance status ≤ 2
Normal bone marrow and organ function as defined below:
- Leukocytes ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcl
- Platelets ≥ 50,000/mcl
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Creatinine ≤ IULN OR Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Patients using antiestrogens for oral birth control are ineligible. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
- A history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Currently receiving any other investigational agents.
- Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DHEA or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with DHEA. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- Known mania-associated psychiatric disorder.
- Known seizure disorder.
- Using corticosteroids or estrogen-based oral birth control.
- Using drugs known to lower or increase levels of DHEA.
- Requires estrogen or testosterone.
- Taking warfarin sodium. Patients on other blood thinners should be monitored for thrombocytopenia.
- Taking a strong inhibitor or inducer of cytochrome P450. Intermediate inhibitors are allowed if deemed medically necessary.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1: DHEA Dose Level 1
-DHEA is an oral supplement which will be administered on an outpatient basis at the prescribed dose daily on a 28-day cycle.
|
Other Names:
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Experimental: Arm 2: DHEA Dose Level 2
-DHEA is an oral supplement which will be administered on an outpatient basis at the prescribed dose daily on a 28-day cycle.
|
Other Names:
|
Experimental: Arm 3: DHEA Dose Level 3
-DHEA is an oral supplement which will be administered on an outpatient basis at the prescribed dose daily on a 28-day cycle.
|
Other Names:
|
Experimental: Arm 4: DHEA Phase II
-DHEA is an oral supplement which will be administered on an outpatient basis at the prescribed dose daily on a 28-day cycle.
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Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD) of DHEA (Phase I only)
Time Frame: Completion of cycle 1 for all phase I patients (estimated to be 2 years)
|
|
Completion of cycle 1 for all phase I patients (estimated to be 2 years)
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Progression-free rate (complete response + partial response + stable disease) (Phase II only)
Time Frame: Up to 5 years
|
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Up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of progression-free survival (PFS) (Phase II only)
Time Frame: 3 months
|
|
3 months
|
Toxicity of DHEA as measured by grade and frequency of adverse events
Time Frame: 30 days after completion of treatment (estimated to be 7 months)
|
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
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30 days after completion of treatment (estimated to be 7 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 13, 2016
Primary Completion (Actual)
September 9, 2018
Study Completion (Actual)
April 4, 2019
Study Registration Dates
First Submitted
February 11, 2016
First Submitted That Met QC Criteria
February 11, 2016
First Posted (Estimate)
February 17, 2016
Study Record Updates
Last Update Posted (Actual)
September 9, 2019
Last Update Submitted That Met QC Criteria
September 4, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201603100
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Synovial Sarcoma
-
Foghorn Therapeutics Inc.Active, not recruitingAdvanced Synovial SarcomaUnited States, Spain, France, Italy
-
OncoTherapy Science, Inc.TerminatedRelapsed or Refractory Synovial SarcomaJapan
-
National Cancer Institute (NCI)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Adult Synovial SarcomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Adult Liposarcoma | Adult Synovial SarcomaUnited States
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C4 Therapeutics, Inc.TerminatedSoft Tissue Sarcoma | Synovial SarcomaUnited States
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Immune DesignTerminatedSarcoma | Soft Tissue Sarcoma | Cancer | Synovial Sarcoma | Metastatic SarcomaUnited States, Canada
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GlaxoSmithKlineCompleted
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GlaxoSmithKlineMerck Sharp & Dohme LLCWithdrawn
-
Fred Hutchinson Cancer CenterIncyte CorporationActive, not recruitingRefractory Soft Tissue Sarcoma | Metastatic Leiomyosarcoma | Metastatic Synovial Sarcoma | Metastatic Undifferentiated Pleomorphic Sarcoma | Advanced Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Advanced Synovial Sarcoma | Metastatic Chondrosarcoma | Advanced Leiomyosarcoma | Metastatic Myxoid... and other conditionsUnited States
-
Eli Lilly and CompanyTerminatedSynovial SarcomaUnited States, Spain, France, United Kingdom, Australia, Germany, Japan, Italy, Belgium, Netherlands
Clinical Trials on DHEA
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EndoCeutics Inc.Completed
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Cairo UniversityCompleted
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National Institute on Aging (NIA)Completed
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Shaare Zedek Medical CenterUnknownInfertility, Female | In-Vitro Fertilization
-
The University of Hong KongCompletedFemale Infertility Due to Diminished Ovarian ReserveHong Kong
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National Center for Complementary and Integrative...Completed
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Virginia Center for Reproductive MedicineWithdrawn
-
Mayo ClinicNational Institutes of Health (NIH); National Institute on Aging (NIA)Completed
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Mayo ClinicNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedAging | Dehydroepiandosterone Replacement | DHEA ReplacementUnited States
-
National Institute on Aging (NIA)Completed