Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
Completed · Phase 2
Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
In brief
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.
Key facts
- Study ID
- NCT00501644
- Run by
- M.D. Anderson Cancer Center
- People needed
- 59
- Starts
- 2003-01-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2012-08-07
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients with Müllerian carcinomas (primary epithelial ovarian, primary peritoneal, or fallopian tube) who have had a response to platinum-based chemotherapy and have a chemotherapy treatment-free interval of at least 6 months. These patients are designated potentially platinum-sensitive.
- Measurable disease by radiological or clinical examination parameters.
- No prior immunotherapy.
- No concurrent steroids or radiation therapy.
- Adequate hematological parameters (ANC >/= 1500 cells/UL, platelets >/= 100,000 cells/UL
- Adequate renal function (serum creatinine </= 1.5 mg/dl)
- Adequate hepatic function (serum bilirubin </= 1.5 mg/dl)
- SGOT or SGPT </= 2.5 normal
- Zubrod status </= 2
- Signed informed consent
- Patients with no more than 2 prior therapy regimens (1st line platinum and platinum reinduction will count as one)
You may not qualify if…
- Pregnant or lactating women
- Patients with brain metastases
- Serum albumin <3 gm/dl
- Weight loss >10% over 4 months
- Radiation therapy to whole abdomen
- History of clinical or EKG findings suggestive of active (within the last 6 months) heart disease
- Patients with active autoimmune or inflammatory bowel disease
- Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
- Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
- Patients with prior hypersensitivity to platinum agents
- Patients with history of other malignancy, with the exception of non-melanomatous skin cancer; unless in complete remission and off therapy for a minimum of 5 years.
Where it is running
- U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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