Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma; Bristol-Myers Squibb; InterMune
• Treatments: Carboplatin; Interferon-gamma; Interferons; Molgramostim; Sargramostim

Criteria

Inclusion Criteria:

1. 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.

2. Measurable disease by radiological or clinical examination parameters.

3. No prior immunotherapy.

4. No concurrent steroids or radiation therapy.

5. Adequate hematological parameters (ANC >/= 1500 cells/UL, platelets >/= 100,000 cells/UL

6. Adequate renal function (serum creatinine

7. Adequate hepatic function (serum bilirubin

8. SGOT or SGPT

9. Zubrod status

10. Signed informed consent

11. Patients with no more than 2 prior therapy regimens (1st line platinum and platinum reinduction will count as one)

Exclusion Criteria:

1. Pregnant or lactating women

2. Patients with brain metastases

3. Serum albumin <3 gm/dl

4. Weight loss >10% over 4 months

5. Radiation therapy to whole abdomen

6. History of clinical or EKG findings suggestive of active (within the last 6 months) heart disease

7. Patients with active autoimmune or inflammatory bowel disease

8. Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.

9. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.

10. Patients with prior hypersensitivity to platinum agents

11. 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.