Clinical Trial: DHEA in Synovial Sarcoma Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Summary:
Sponsor: Washington University School of Medicine
Current Primary Outcome:
- 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) ]
- 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%)
- Progression-free rate (complete response + partial response + stable disease) (Phase II only) [ Time Frame: Up to 5 years ]
- 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 shrinka
Original Primary Outcome:
- 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) ]
- 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%)
- Objective response rate (complete response + partial response + stable disease) (Phase II only) [ Time Frame: Up to 5 years ]
- 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 shrin
Current Secondary Outcome:
- Rate of progression-free survival (PFS) (Phase II only) [ Time Frame: 3 months ]
- 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.
- 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.
Original Secondary Outcome: Same as current
Information By: Washington University School of Medicine
Dates:
Date Received: February 11, 2016
Date Started: September 13, 2016
Date Completion: June 30, 2025
Last Updated: April 11, 2017
Last Verified: April 2017
- Rate of progression-free survival (PFS) (Phase II only) [ Time Frame: 3 months ]
- 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) ]