GCSF primed peripheral blood stem cells (pbsc) are a source of hematopoietic reconstruction after high dose chemotherapy. 21 patients with advanced malignancy (small cell lung, ovarian, breast, sarcoma, lymphoma, germ cell, medulloblastoma, cervical) have been treated as follows: cyclophosphamide 4 mg/m2 followed by GCSF 10mcg/kg per day from day +2 until large volume leukophoresis (LVL) is completed; 4 cycles of (CCE) cyclophosphamide 3gm/m2, carboplatinum 1 gm/m2, and etoposide 80-540mg/m2 (dose escalation) followed by infusion of 1/4 of the PBSC collection on the 3rd day after chemotherapy. GCSF 5mcg/mg per day is administered until ANC > 1000 for 3 days. All treatment is delivered in an outpatient setting. LVL is performed over 1-4 days with CD34 collection ranging from 4.7 x 10/6 per kilogram to 5.7 x 10/7 per patient. 91 cycles of high dose therapy have been administered to 21 patients. 53 cycles have been complicated by hospitalization (51 for fever neutropenia). The median duration of hospitalization is 5 days. 70 cycles of CCE have been administered. The median number if days to ANC > 500 is 10 days. The median time to platelet > 20K without transfusion is 12 days. The median interval between treatment cycles is 21 days. No deaths were atributable to therapy. 2 patients were withdrawn form the study for prolonged thrombocytopenia. 1 cycle was complicated by grade IV infection and 2 cycles by grade IV diarrhea. There were no other grade IV nonhematologic toxicities. 1 cycle was complicated by grade III infection, 1 cycle by grade III diarrhea, 1 cycle by grade III hematuria. 1 patient required a dose reduction for slow platelet recovery. All patients are accessible for response. There have been 5 CRs and 10 PRs. Dose intense chemotherapy can be administered on an outpatient basis with acceptable toxicity with the use of cyclophosphamide/GCSF mobilized PBSC support.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000054-36A1
Application #
6245513
Study Section
Project Start
1997-05-01
Project End
1997-11-30
Budget Start
1996-10-01
Budget End
1997-09-30
Support Year
36
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Tufts University
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02111
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