Recurrent Ovarian Carcinoma Clinical Trial
Official title:
Study of Serum Measured Folate Receptor and Its Induction as a Biomarker in the Diagnosis and Surveillance of Ovarian Carcinoma
This pilot research trial studies folate receptor in diagnosing ovarian cancer using serum samples from patients with a newly diagnosed pelvic mass or previously diagnosed ovarian cancer. Studying samples of serum from patients with ovarian cancer in the laboratory may help understand the use of folate receptor induction as a clinical tool in initial diagnosis, surveillance, and recurrence.
PRIMARY OBJECTIVES:
I. To evaluate the pre- and post-induction correlation between soluble folate receptor and
tumor-based receptor levels as a marker of malignancy in patients with newly diagnosed
adnexal masses. (Arm I) II. To evaluate the ability to induce serum folate receptor (FR) with
dexamethasone (Dex) and valproic acid (VPA) treatment in patients with newly diagnosed
adnexal masses. (Arm I) III. To evaluate the use of the serum soluble FR as a marker for
earlier detection of recurrent disease. (Arm II) IV. To evaluate the ability to induce FR
with Dex and VPA in the setting of recurrent disease. (Arm II)
SECONDARY OBJECTIVES:
I. To evaluate the expression of FR in primary versus (vs.) metastatic tumor sites in
patients with ovarian malignancy undergoing Dex and VPA induction and correlate expression
with other markers associated with malignancy (marker of proliferation Ki-67 [Ki67], cancer
antigen [CA]-125, etc.).
II. To analyze the correlation between gluco-corticoid receptor (GR) levels and serum FR
induction efficacy.
III. To examine global, downstream targets of GR and FR induction in patient samples
undergoing treatment with Dex and VPA.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (INDUCTION): Patients receive valproic acid orally (PO) twice daily (BID) on days -7 to
-3 and once daily (QD) on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4
and -3. Patients undergo collection of serum and tissue samples for analysis via polymerase
chain reaction (PCR) and immunohistochemistry (IHC) at baseline, time of surgery, and 7-14
days after surgery.
ARM II (SURVEILLANCE AND RECURRENCE): Patients receive valproic acid PO BID on days -7 to -3
and QD on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3.
Patients undergo collection of serum and tissue samples for analysis via PCR and IHC at the
time of clinically suspected recurrence, 2 days after completion of induction, and 7-14 days
after induction.
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