Clinical trial NCT00004157: 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
Official title: Combination of Interleukin 11 (Neumega) With G-CSF to Mobilize Autologous Peripheral Blood Stem Cells (PBSC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Gestational Trophoblastic Tumor
Kidney Cancer
Lymphoma
Neuroblastoma
Ovarian Cancer
Sarcoma
Testicular Germ Cell Tumor
Keywords: 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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-02-12
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Leona A. Holmberg, MD, PhD
role: STUDY_CHAIR
References: