Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Carboplatin; GM-CSF (Sargramostim); Interferon Gamma
Intervention description: 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).
Intervention MeSH terms: Interferons; Interferon-gamma; Carboplatin; Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: Female
Healthy volunteers: No
Keywords: Müllerian Carcinomas; Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer; Epithelial Ovarian; Peritoneal; Fallopian Tube; Chemoimmunotherapy; Platinum Sensitive Müllerian; Carboplatin; Paraplatin; GM-CSF; Sargramostim; Interferon Gamma; Quality of Life; QOL

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.
    

Eligibility 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 </= 1.5 mg/dl)

          7. Adequate hepatic function (serum bilirubin </= 1.5 mg/dl)

          8. SGOT or SGPT </= 2.5 normal

          9. Zubrod status </= 2

         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.