Auranofin and Sirolimus in Treating Participants With Ovarian Cancer

• Status: Active, not recruiting
• Trial end date: 2023-03-15
• Target enrollment: 0
• Participant gender: Female

Summary

This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Auranofin; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

• Ovarian, Fallopian Tube or Primary Peritoneal cancer of serous histology

• Incurable cancer

• Willingness to provide paraffin-embedded tissue blocks of ovarian cancer

• Measurable disease

• Obtained =< 14 days prior to registration: Absolute neutrophil count (ANC) >= 1500 uL

• Obtained =< 14 days prior to registration: Platelet (PLT) >= 100,000 uL

• Obtained =< 14 days prior to registration: Hemoglobin (Hgb) >= 9 g/dL

• Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN

• Obtained =< 14 days prior to registration: Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN is acceptable if liver has tumor involvement

• Obtained =< 14 days prior to registration: Creatinine =< 1.5 x ULN

• Obtained =< 14 days prior to registration: Fasting serum glucose =< 1.5 x ULN

• Obtained =< 14 days prior to registration: Total cholesterol =< 1.5 x ULN

• Obtained =< 14 days prior to registration: Triglycerides =< 1.5 x ULN

• Life expectancy >= 12 weeks

Exclusion Criteria:

• Platinum-sensitive disease (exceptions allowed: patient has had a hypersensitivity reaction to platinum or the treating oncologist thinks that further platinum therapy is not in the patient?s best interest)

• Morbidities or concurrent major illness (for example, bowel obstruction or a second active malignancy) that, in the opinion of the treating healthcare provider, would make participation in the trial problematic

• Leptomeningeal disease or uncontrolled brain metastasis

• Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment

• NOTE: Patients can have peripheral (sensory) neuropathy

• History of hypertriglyceridemia or hypercholesterolemia and currently on medication(s)

• Use of St. John?s wort =< 7 days prior to registration

• Unable to discontinue use of a strong CYP3A4 inhibitor