Trials / Completed
CompletedNCT00004157
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
- Breast Cancer
- Gestational Trophoblastic Tumor
- Kidney Cancer
- Lymphoma
- Neuroblastoma
- Ovarian Cancer
- Sarcoma
- Testicular Germ Cell Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | filgrastim | |
| BIOLOGICAL | recombinant interleukin-11 |
Timeline
- Start date
- 2000-08-01
- Primary completion
- 2002-04-01
- Completion
- 2002-04-01
- First posted
- 2004-02-12
- Last updated
- 2010-04-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00004157. Inclusion in this directory is not an endorsement.