To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while producing treatment failure (defines as death, grade 3/4 toxicity, or progressive disease) in 40% or less of patients.

Condition	Treatment or Intervention	Phase
Acute Graft Versus Host Disease	Drug: pentostatin for injection	Phase I Phase II

Ages Eligible for Study:  6 Months and above,  Genders Eligible for Study:  Both

Criteria

Inclusion:

• Patients 6 months of age with grade 2 GVHD that is steroid-refractory
• Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets and PRBC
• Time post stem cell infusion < 100 days
• Written informed consent
• Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2

Exclusion:

• Post-transplant lymphoproliferative disease
• Uncontrolled infection
• Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study
• ATG within the previous 14 days
• Other immunosuppressive agents (including monoclonal antibodies) when initiated within the previous 7 days.

Emel Bayar, MD      925-560-0100  Ext. 404    EBayar@supergen.com

Texas
      MD Anderson Cancer Center, Houston,  Texas,  United States; Recruiting

Study ID Numbers:  SGI-NIP-010; NIP-010
Record last reviewed:  April 2002
Record first received:  April 2, 2002
ClinicalTrials.gov Identifier:  NCT00032773
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10