GM-CSF in Women With Recurrent Ovary Cancer

Ovarian Cancer Clinical Trial

Official title: Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

This is an open labeled, single arm phase II study of GM-CSF 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer

• NCT number: NCT00157573
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Phase 2
• Start date: December 2004
• Completion date: April 2010