GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Granulocyte macrophage colony-stimulating factor (GM-CSF) is an immunostimulant and preliminary data suggests it may change the natural history of prostate cancer and melanoma. This study looks at ability of GM-CSF to alter disease progression in women who have recurrent but asymptomatic recurrence of their ovarian cancer.

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

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Bayer; Dana-Farber Cancer Institute
• Treatments: Sargramostim

Criteria

Inclusion Criteria:

• Patients must have a history of histologic or cytologic diagnosis of primary ovarian, primary peritoneal or tubal carcinoma.

• Patients must be asymptomatic from their cancer.

• Patients must have evidence of recurrent carcinoma, as determined by:

• A rising cancer antigen 125 (CA-125) serum level greater than 35 U/mL or two successive rising values with the most recent value at least 3 times the nadir value.

• Or evidence of evaluable or measurable disease by x-ray or computed tomography (CT) scan.

• Patients may not receive concurrent antineoplastic therapy. All hormonal therapy used as a treatment modality (i.e. tamoxifen, arimidex, etc) must be stopped prior to treatment on protocol.

• Age > 18 years.

• Eastern Cooperative Oncology Group (ECOG) performance status < 2.

Exclusion Criteria:

• Known severe hypersensitivity to GM-CSF.

• Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or concurrent superficial or stage IB endometrial carcinoma.

• Concomitant use of anti-neoplastic therapy.

• Treatment with a non-FDA approved or investigational drug within 30 days before Day 1 of trial treatment.

• Any unresolved chronic toxicity greater then Common Toxicity Criteria (CTC) grade 2 from previous anticancer therapy (except alopecia).

• Serum creatinine level greater than CTC grade 2 [1.5 x upper limit normal (ULN)].

• Pregnancy or breast feeding (women of childbearing potential).

• Severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as judged by the investigator.

• Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate in the trial as judged by the investigator.

• Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment.

• Patients with clinical and/or radiographic evidence of current or impending bowel obstruction.

• Performance status < 1.

• Ability to understand and the willingness to sign a written informed consent document.