Folate Receptor in Diagnosing Ovarian Cancer Using Serum Samples From Patients With Newly Diagnosed Pelvic Mass or Previously Diagnosed Ovarian Cancer

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ichthammol; Valproic Acid

Criteria

Inclusion Criteria:

• For study Arm 1, female subjects of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion unless total hysterectomy performed at the time of original operation

• Able to provide informed consent

• Performance status Eastern Cooperative Oncology Group (ECOG) 0-2

• Study Arm 1: primary diagnosis of a pelvic or adnexal mass of presumed gynecologic origin who is scheduled for operative resection

• Study Arm 2: previously diagnosed with a non-mucinous epithelial ovarian carcinoma (including serous, clear cell, and endometrioid histologies as well as borderline ovarian tumors) currently undergoing routine surveillance for recurrence, having been diagnosed with recurrence but prior to initiation of chemotherapy. . Patients from Study Arm 1 will automatically be included in Study Arm 2 as well unless they withdraw consent. Finally, patients who have been diagnosed with an ovarian cancer of acceptable histology but not yet initiated adjuvant chemotherapy are eligible for Study Arm 2.

Exclusion Criteria:

• Known sarcomatous histologies

• Current usage of VPA or Dex, if patient has been on these medications in the past but is not currently taking them she is still a candidate for the study. Prior use must be greater than one month for VPA. There is no "wash out" period required for DEX.

• Any contraindication to dexamethasone or valproic acid such as known allergies or sensitivity

• Unable to give informed consent

• Pregnancy

• Greater than 3 x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST)

• Greater than 3 x the ULN for total bilirubin (except for known cases of Gilbert's syndrome, where the levels of conjugated bilirubin must be less than 3 x the ULN)

• Greater than 1.5 x the ULN for blood urea nitrogen (BUN)

• Greater than 1.5 x the ULN for creatinine

• Chronic or acute pancreatitis as evidenced by clinical or pathologic diagnosis

• Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study

• For study Arm 2, patients that are currently undergoing chemotherapy for recurrence; maintenance chemotherapy is not considered an exclusion criteria. Additionally, as noted above if a patient has not yet begun chemotherapy for recurrence or adjuvant chemotherapy for initial diagnosis they are still a candidate to be enrolled on this Study arm.