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	Treatment or Intervention	Phase
Testicular Cancer ovarian epithelial cancer Lymphoma Breast Cancer kidney tumor	Procedure: biological response modifier therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: interleukin therapy  Drug: filgrastim  Drug: interleukin-11	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  up to  70 Years

Criteria

PROTOCOL ENTRY 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

--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

--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

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States

Study chairs or principal investigators

Leona Holmberg,  Study Chair,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000067395; FHCRC-1365.00; NCI-G99-1622
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004157
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08