Conditions: Ovarian Cancer Fallopian Tube Cancer
Keywords: Asymptomatic Clinical trial Phase II GM-CSF Immunotherapy
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 72
Healthy volunteers: no

Brief 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.

Detailed description:
This is an open labeled, single arm phase II study of GM-CSF, sargramostim delivered daily without a break in a population of healthy and fit women with evidence of recurrent but asymptomatic mullerian malignancy (such as ovarian cancer, fallopian tube cancer, or primary peritoneal cancer). The main goal is to determine the time to treatment termination due to disease progression or toxicity.

Arms:
arm 1: GM-CSF, Sargramostim 250 μg/m\^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. arm 2: GM-CSF, sargramostim 150 μg/m\^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity fora median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m\^2 per day if applicable based on toxicity and white blood cell count.

Interventions: intervention 1: GM-CSF, sargramostim
Intervention descriptions: intervention 1: GM-CSF subcutaneous injection

Protocol document: