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 has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00004157
First received: December 10, 1999
Last updated: March 31, 2010
Last verified: March 2010

December 10, 1999
March 31, 2010
August 2000
April 2002   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004157 on ClinicalTrials.gov Archive Site
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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
Combination of Interleukin 11 (Neumega) With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells (PBSC)

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Breast Cancer
  • Gestational Trophoblastic Tumor
  • Kidney Cancer
  • Lymphoma
  • Neuroblastoma
  • Ovarian Cancer
  • Sarcoma
  • Testicular Germ Cell Tumor
  • Biological: filgrastim
  • Biological: recombinant interleukin-11
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2002
April 2002   (final data collection date for primary outcome measure)

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

Both
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004157
1365.00, FHCRC-1365.00, NCI-G99-1622, CDR0000067395
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Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: Leona A. Holmberg, MD, PhD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP