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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
* Baseline, Cycle 1 Day 15, and Day 1 of each cycle beginning with Cycle 2 * 7 questions with answers ranging from 0=Not At All to 4 = Very Much.
Washington University School of Medicine
St Louis, Missouri, United States
Maximum tolerated dose (MTD) of DHEA (Phase I only)
* MTD is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed until the MTD has been reached. * Dose-limiting toxicities are defined as one of the following events occurring during the 1st cycle of treatment thought to be possibly, probably, or definitely related to treatment: * Grade 3 or greater liver function test abnormalities * Grade 3 or greater psychiatric disorder * Quality of life (QOL) alteration (change in score of 30%)
Time frame: Completion of cycle 1 for all phase I patients (estimated to be 2 years)
Progression-free rate (complete response + partial response + stable disease) (Phase II only)
* Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction inf short axis to \<10mm, disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diaters while on study
Time frame: Up to 5 years
Rate of progression-free survival (PFS) (Phase II only)
* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive disease (PD): aAppearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time frame: 3 months
Toxicity of DHEA as measured by grade and frequency of adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
-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.
Time frame: 30 days after completion of treatment (estimated to be 7 months)