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Phase I/II Study of Escalating-Dose IL-6 with GM-CSF Prior to ABMT, with Randomization to IL-6/GM-CSF vs GM-CSF Following ABMT, for Nonhematologic Malignancies (Summary Last Modified 11/94)
Basic Trial Information
Objectives I. Assess the safety and toxicity of repetitive daily doses of interleukin-6 (IL-6) administered with granulocyte-macrophage colony stimulating factor (GM-CSF) prior to and following myelosuppressive chemotherapy and autologous bone marrow transplantation in patients with nonhematologic malignancies. II. Identify a safe and effective biologic dose and/or maximum tolerated dose of IL-6 for future clinical testing. III. Evaluate the rate of hematopoietic recovery after myelosuppressive chemotherapy and the influence of IL-6 on attenuation of thrombocytopenia or acceleration of platelet count recovery. IV. Assess any change in the safety, tolerance, or treatment-limiting toxicities of IL-6 given in combination with GM-CSF. Entry Criteria Disease Characteristics: Biopsy-proven nonhematologic tumor with histologic or clinical evidence of advanced disease The following tumor types are eligible: Stage II/III breast cancer with 10 or more positive nodes Stage IV breast cancer that is hormone refractory, with or without prior chemotherapy Stage II/III ovarian cancer with at least 1 prior course of platinum-based therapy Limited or extensive stage small cell lung cancer Germ cell tumors that failed first-line therapy Dukes' Stage C/D or recurrent colon cancer Pancreatic cancer of any stage Incompletely resected gastric or esophageal cancer No history of any of the following: Kaposi's Sarcoma Multiple myeloma/monoclonal gammopathy B- or T-cell neoplasm Eligible for autologous bone marrow transplantation at a participating institution At least 1.5 x 10 to the eighth total noncleaved cells/kg harvested Marrow free of tumor Breast cancer patients may have marrow that is positive on immunocytochemistry only Any CNS metastases must have been excised or irradiated at least 3 months previously and patient must be clinically stable with no history of seizures Pretreatment marrow cellularity adequate Hormone receptor status: Not specified Prior/Concurrent Therapy: See Disease Characteristics No prior interleukin-6 No plans to purge bone marrow either chemically or with monoclonal antibodies Patient Characteristics: Age: 18 and over Performance status: Able to meet institutional eligibility requirements Hematopoietic: AGC at least 1,500 Platelets at least 150,000 but no more than 500,000 Hb at least 10.0 g/dl (may transfuse) Hepatic: Bilirubin no more than 1.5 mg/dl SGOT and SGPT no more than 2.0 x ULN PT and PTT no more than 1.5 x control Renal: Creatinine no more than 2.0 mg/dl Proteinuria and hematuria no more than 1+ Other: Able to meet institutional cardiac and pulmonary function requirements for autologous bone marrow transplantation No history of allergy to gentamicin or gentamicin analogues HIV and hepatitis B seronegative No autoimmune disease (e.g., severe rheumatoid arthritis, widespread active psoriasis) No pregnant or nursing women Adequate contraception required of sexually active, fertile women Expected Enrollment Up to 26 patients will be enrolled. Outline Randomized study. All patients are treated on Regimen A. Following a preparative regimen (high-dose chemotherapy with or without radiotherapy) and autologous bone marrow transplantation (ABMT), patients are randomized 3:1 to Arms I and II. Regimen A: Hematopoietic Stimulation. Interleukin-6 (Serono), IL-6, NSC-658932; Granulocyte-Macrophage Colony Stimulating Factor Therapy (Immunex), GM-CSF, NSC-613795. Arm I: Hematopoietic Stimulation. IL-6; GM-CSF. Arm II: Hematopoietic Stimulation. GM-CSF. Trial Lead Organizations Fred Hutchinson Cancer Research Center
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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