At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Chemoimmunotherapy for Patients With Potentially Platinum Sensitive Müllerian (Epithelial Ovarian, Peritoneal, or Fallopian Tube) Carcinomas
In Brief
A Phase 2 clinical trial evaluating Carboplatin, GM-CSF (Sargramostim), and 1 other intervention for Ovarian Cancer and 2 related conditions. Completed, enrolled 59 participants across 1 site.
Detailed Summary
Primary Objectives: 1. Determine response rate, time to progression, and toxicity of a schedule of carboplatin by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in patients with potentially platinum-sensitive recurrent Müllerian carcinomas. 2. Determine whether this treatment schedule is associated with: 1. increased levels of monocytes (\>2-fold and absolute numbers 1000 cells/ml,) and of LN-DR+ DC (CD11c+ and CD123+ subsets) 2. induction of priming and activation of MO/MA (monocytes/ macrophages), and maturation of DC (dendritic cells). 3. Determine the toxicity profile of consolidation treatment with IP (intraperitoneal) injections of rIFN-g added to carboplatin (IV) and GM-CSF (SC) for 4 doses/course. 4. Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in patients with platinum-sensitive Müllerian carcinomas. 5. To begin an exploration of cell surface proteins on purified activated peripheral blood and ascites monocyte/macrophages both before and after treatment with GM-CSFand rIFN-g.
Study Details
Timeline
Interventions
AUC of 5 by 1 hour IV infusion every 28 days.
Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy.
0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle).