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Phase I/II Study of PIXY321 (GM-CSF/IL-3 S. cerevisiae Fusion Protein) in Combination with CTX/CBDCA in Patients with Advanced Epithelial Ovarian Cancer
Basic Trial Information
Objectives I. Evaluate the safety of daily subcutaneous granulocyte-macrophage colony stimulating factor/interleukin-3 S. cerevisiae fusion protein (PIXY321) following chemotherapy with cyclophosphamide/carboplatin (CTX/CBDCA) in patients with advanced ovarian cancer. II. Determine the MTD and/or optimum biologic dose of PIXY321 given after CTX/CBDCA in patients with advanced ovarian cancer. Entry Criteria Disease Characteristics: Histologically diagnosed, Stage II/III/IV epithelial ovarian carcinoma Prior/Concurrent Therapy: Biologic therapy: No prior colony stimulating factor therapy (including GM-CSF, G-CSF, IL-3, IL-2, or interferon) No concurrent immunotherapy Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: Prior cytoreductive surgery, as feasible, required Other: At least 4 weeks since treatment with any investigational agent No concurrent treatment with any medication that may interfere with interpretation of study results (e.g., steroids, lithium, immunosuppressive or myelosuppressive agents) Patient Characteristics: Age: 18 to 70 Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dl SGOT/SGPT no greater than 2 x ULN Renal: Creatinine no greater than 1.5 mg/dl Creatinine clearance at least 60 ml/min Cardiovascular: No significant cardiac disease within previous 6 months No history of MI within previous 6 months No CHF within previous 6 months No uncontrolled hypertension Pulmonary: No asthma (even if controlled with medication) Other: No HBsAg positivity No known HIV positivity No significant active infection (e.g., pneumonia, peritonitis, wound abscess) No other serious intercurrent illness (e.g., uncontrolled metabolic disease such as diabetes mellitus, hypothyroidism) No dementia or altered mental status that would preclude informed consent No second malignancy except: Curatively treated nonmelanomatous skin cancer Curatively treated in situ cervical carcinoma No pregnant women (negative pregnancy test required of fertile women within 1 week of entry) Effective contraception required of fertile patients Expected Enrollment 15 to 20 patients will be treated, with a possible 6 additional patients treated at the OBD. The study is expected to be completed in 6-12 months. Outline Nonrandomized study. 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. Cyclophosphamide, CTX, NSC-26271; Carboplatin, CBDCA, NSC-141540; with Granulocyte-Macrophage Colony Stimulating Factor/Interleukin-3 S. cerevisiae fusion protein (Immunex), PIXY321.Published Results Runowicz CD, Mandeli J, Speyer J, et al.: Phase I/II study of PIXY321 in combination with cyclophosphamide (CTX) and carboplatin (CP) in the treatment of patients (PTS) with ovarian cancer (OC). [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-825, 260, 1993. Trial Lead Organizations Albert Einstein Cancer Center at Albert Einstein College of Medicine
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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