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DHEA in Synovial Sarcoma Patients

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Disease Information

Descriptive Information
Brief Title † DHEA in Synovial Sarcoma Patients
Official Title † A Phase I/II Clinical Trial of Dose-Escalating DHEA in Synovial Sarcoma Patients
Brief Summary 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.
Detailed Description
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Maximum tolerated dose (MTD) of DHEA (Phase I only)
Secondary Outcome Measure † Rate of progression-free survival (PFS) (Phase II only)
Condition † Synovial Sarcoma Sarcoma, Synovial
Intervention † DrugDHEA
Study Arms / Comparison Groups 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. 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. 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. 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.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 47
Start Date † September 13, 2016
Completion Date June 30, 2025
Primary Completion Date June 30, 2025
Eligibility Criteria † Inclusion Criteria: - Diagnosis of histologically or cytologically confirmed metastatic or non-resectable synovial sarcoma. - Failed 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.
Gender All
Ages 16 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Brian A Van Tine, M.D., Ph.D., 314-362-5737, bvantine@wustl.edu
Location Countries † United States
Administrative Information
NCT ID † NCT02683148
Organization ID 201603100
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Washington University School of Medicine
Collaborators ††
Investigators † Principal Investigator: Brian A Van Tine, M.D., Ph.D., Washington University School of Medicine
Information Provided By
Verification Date April 2017
First Received Date † February 11, 2016
Last Updated Date April 11, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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