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Interleukin-11 Plus Filgrastim Prior to Peripheral Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, Breast Cancer, or Other Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004157
  Purpose

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
Breast Cancer
Gestational Trophoblastic Tumor
Kidney Cancer
Lymphoma
Neuroblastoma
Ovarian Cancer
Sarcoma
Testicular Germ Cell Tumor
Biological: filgrastim
Biological: recombinant interleukin-11
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Hodgkin's Disease Kidney Cancer Lymphoma Neuroblastoma Ovarian Cancer Soft Tissue Sarcoma
Drug Information available for: Filgrastim Oprelvekin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Combination of Interleukin 11 (Neumega) With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells (PBSC)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004157

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Leona A. Holmberg, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067395, FHCRC-1365.00, NCI-G99-1622
Study First Received: December 10, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004157     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Lymphoma, Mantle-Cell
Seminoma
Mantle Cell Lymphoma
Urogenital Neoplasms
Urologic Neoplasms
Follicular Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Wilms' Tumor
Neuroepithelioma
Ovarian Cancer
Kidney Diseases
Hodgkin Disease
Breast Diseases
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Testicular Cancer
Hydatidiform Mole
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Testicular Neoplasms
Carcinoma
Neuroectodermal Tumors
Malignant Mesenchymal Tumor
B-cell Lymphomas
Gestational Trophoblastic Neoplasms
Sarcoma

Additional relevant MeSH terms:
Pregnancy Complications
Neuroectodermal Tumors, Primitive
Antineoplastic Agents
Gonadal Disorders
Neoplasms, Nerve Tissue
Urogenital Neoplasms
Ovarian Diseases
Urologic Neoplasms
Neuroblastoma
Genital Diseases, Female
Oprelvekin
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Lymphoma, Large-Cell, Immunoblastic
Trophoblastic Neoplasms
Kidney Diseases
Lymphoma
Breast Diseases
Endocrine Gland Neoplasms
Pregnancy Complications, Neoplastic
Immunoproliferative Disorders
Ovarian Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Skin Diseases
Genital Neoplasms, Female
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 07, 2009