Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Non-Hodgkin's LymphomaHodgkin's DiseaseMultiple MyelomaOther Plasma Cell Dyscrasia (Waldenstrom, Amyloidosis)Leukemia
Interventions
DRUG

GM-CSF

"GM-CSF (Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor) The dose and duration of GM-CSF (7.5 mcg/kg/day) was selected. If used alone, this dose and duration would result in effective mobilization. GM-CSF will be started on Day #7 and will continue until completion of leukapheresis.~G-CSF will be started (5mcg/kg/d) on Day #7 and will be given each morning. G-CSF will continue until completion of leukapheresis."

DRUG

IL-2

"IL-2 dose escalation: IL-2 will be administered as a single daily subcutaneous injection each evening until completion of leukapheresis.~Escalation of the dose of IL-2 will be performed using the below schema with the following levels. Patients will be started on Level 1. (Level 0 is included since, if toxicity is meet in Level 1, the dose will be decreased to Level 0).~Level 0 - 3 x 105 i.u./m2/day for 11 days Level 1 - 6 x 105 i.u./m2/day for 11 days Level 2 - 1 x 106 i.u. /m2/day for 11 days as above Level 3 - 1.5 x 106 i.u. /m2/day for 11 days as above Level 4 - 2 x 106 i.u. /m2/day for 11 days as above"

Trial Locations (1)

03756

Dartmouth-Hitchcock Medical Center, Lebanon

All Listed Sponsors
lead

Dartmouth-Hitchcock Medical Center

OTHER

NCT00952237 - Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF | Biotech Hunter | Biotech Hunter