Combination of Interleukin 11 (Neumega) With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells (PBSC)
Phase 2
N/A
70 Years
N/A
70 Years
Not Enrolling
Both
Breast Cancer, Gestational Trophoblastic Tumor, Kidney Cancer, Lymphoma, Neuroblastoma, Ovarian Cancer, Sarcoma, Testicular Germ Cell Tumor
Both
Breast Cancer, Gestational Trophoblastic Tumor, Kidney Cancer, Lymphoma, Neuroblastoma, Ovarian Cancer, Sarcoma, Testicular Germ Cell Tumor
Trial Information
Combination of Interleukin 11 (Neumega) With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells (PBSC)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Leona A. Holmberg, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1365.00
NCT ID:
NCT00004157
Start Date:
August 2000
Completion Date:
April 2002
Related Keywords:
- Breast Cancer
- Gestational Trophoblastic Tumor
- Kidney Cancer
- Lymphoma
- Neuroblastoma
- Ovarian Cancer
- Sarcoma
- Testicular Germ Cell Tumor
- 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
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent ovarian germ cell tumor
- ovarian yolk sac tumor
- ovarian embryonal carcinoma
- ovarian polyembryoma
- ovarian choriocarcinoma
- ovarian immature teratoma
- ovarian mature teratoma
- ovarian monodermal and highly specialized teratoma
- ovarian mixed germ cell tumor
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- poor prognosis metastatic gestational trophoblastic tumor
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- previously treated childhood rhabdomyosarcoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Breast Neoplasms
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Hodgkin Disease
- Lymphoma
- Lymphoma, Non-Hodgkin
- Neuroblastoma
- Ovarian Neoplasms
- Trophoblastic Neoplasms
- Lymphoma, Large-Cell, Immunoblastic
- Neoplasms, Germ Cell and Embryonal
- Gestational Trophoblastic Neoplasms
- Sarcoma
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
