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NCT00501644 · ClinicalTrials.gov registry record · Phase 2
Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT00501644: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00501644 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00501644, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study 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.
Interventions
- DRUG Carboplatin
- DRUG GM-CSF (Sargramostim)
- DRUG Interferon Gamma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2003-01 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00501644
The ClinicalTrials.gov registry entry for NCT00501644 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT00501644 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00501644 about?
NCT00501644 is a clinical study titled "Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer". 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 tre...
What is the current status of trial NCT00501644?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2003-01. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00501644?
The interventions under investigation include: Carboplatin (DRUG), GM-CSF (Sargramostim) (DRUG), Interferon Gamma (DRUG).
Who is sponsoring clinical trial NCT00501644?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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