DHEA in Synovial Sarcoma Patients

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.