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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004157 |
RATIONALE: Interleukin-11 and filgrastim stimulate the production of blood cells. Giving these drugs to stimulate peripheral stem cells that can be collected for peripheral stem cell transplantation may result in fewer side effects after transplant.
PURPOSE: Phase II trial to study the effectiveness of interleukin-11 plus filgrastim prior to peripheral stem cell transplantation in patients who have non-Hodgkin's lymphoma, Hodgkin's disease, breast cancer, or other solid tumors.
Condition | Intervention | Phase |
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Breast Cancer Gestational Trophoblastic Tumor Kidney Cancer Lymphoma Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor |
Drug: filgrastim Drug: recombinant interleukin-11 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Combination of Interleukin 11 (Neumega) With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells (PBSC) |
Study Start Date: | August 2000 |
OBJECTIVES: I. Determine the tolerability of interleukin-11 (IL-11) with filgrastim (G-CSF) in patients with non-Hodgkin's lymphoma, Hodgkin's disease, breast cancer, or other solid tumors. II. Evaluate the ability to collect CD34 cells and the number of apheresis collections required to reach the target number of CD34 cells in this patient population. III. Evaluate the time to recovery of platelets and neutrophils and the number of platelet and red blood cell transfusions required following IL-11 and G-CSF mobilized peripheral blood stem cell infusion in these patients.
OUTLINE: Patients receive interleukin-11 (IL-11) subcutaneously (SQ) on days 1-10 and filgrastim (G-CSF) SQ on days 4-10. Patients undergo peripheral blood stem cell (PBSC) collection on days 7-10 until the target number of cells is achieved or for a maximum of 4 collections. Patients are followed until transplantation.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of non-Hodgkin's lymphoma, Hodgkin's disease, breast cancer, or other solid tumors with eligibility for FHCRC/PSOC protocols involving autologous peripheral blood stem cell transplantation No evidence of bone marrow disease No pericardial effusion, pleural effusion, or ascites No CNS involvement Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 70 and under Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL No medically unmanageable, severe hypokalemia Cardiovascular: No history of atrial arrhythmia or congestive heart failure No history of thromboembolic disease, except successfully treated catheter related thrombosis LVEF at least 45% Other: No active infection requiring systemic antibiotics HIV negative No known allergy to murine or E. coli proteins No documented prior anaphylactic reaction to interleukin-11 or filgrastim (G-CSF) No papilledema No history of Factor V Leiden defect, factor II, antithrombin III, Protein C or Protein S deficiencies Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: No prior cumulative dose of doxorubicin greater than 300 mg/m2 At least 3 weeks since prior chemotherapy Endocrine therapy: No concurrent estrogen supplementation Radiotherapy: No prior radiotherapy to the pelvic area Surgery: Not specified Other: No chronic diuretic therapy At least 1 week since prior aspirin or anticoagulants except low dose anticoagulation to prevent catheter thrombosis
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | Leona A. Holmberg, MD, PhD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000067395, FHCRC-1365.00, NCI-G99-1622 |
Study First Received: | December 10, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004157 |
Health Authority: | United States: Federal Government |
stage IV breast cancer stage IIIA breast cancer stage IIIB breast cancer recurrent adult Hodgkin lymphoma recurrent childhood rhabdomyosarcoma stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer disseminated neuroblastoma recurrent neuroblastoma recurrent Wilms tumor and other childhood kidney tumors recurrent childhood lymphoblastic lymphoma stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor |
testicular embryonal carcinoma testicular choriocarcinoma testicular teratoma testicular yolk sac tumor testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and teratoma with seminoma testicular embryonal carcinoma and yolk sac tumor testicular embryonal carcinoma and yolk sac tumor with seminoma testicular embryonal carcinoma and seminoma testicular yolk sac tumor and teratoma testicular yolk sac tumor and teratoma with seminoma testicular choriocarcinoma and yolk sac tumor testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and seminoma |
Neuroectodermal Tumors, Primitive Hodgkin lymphoma, adult Malignant mesenchymal tumor Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Seminoma Urogenital Neoplasms Ovarian epithelial cancer Urologic Neoplasms Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Leukemia, Lymphocytic, Chronic, B-Cell Neuroepithelioma Kidney Diseases Hodgkin Disease |
Breast Diseases Rhabdomyosarcoma Endocrine Gland Neoplasms Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia, B-cell, chronic Hydatidiform Mole Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Renal cancer Testicular Neoplasms Carcinoma Neuroectodermal Tumors |
Neoplasms Pregnancy Complications, Neoplastic Neoplasms by Histologic Type Neoplasms by Site Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Pharmacologic Actions Adnexal Diseases |