SWOG clinical trial number
C90003

Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study

Closed
Phase
Abbreviated Title
Renal
Activated
09/01/2002
Closed
04/15/2004
Participants
Limited Institutions: BMT Members

Research committees

Genitourinary Cancer

Treatment

Cyclophosphamide Filgrastim Fludarabine Phosphate Methotrexate Tacrolimus

Eligibility Criteria Expand/Collapse

Pt must have histologic doc of met or unresectable RCC. Pts w/clear cell or pap RCC are eligible. Pt must have mx disease; have rec'd prior IFN-a and/or IL-2 and have PD or be intolerant of this therapy. Pt must not have rec'd systemic therapy for RCC w/in 28 days prior to tx and at least 14 days must have elapsed since RT or surgery. Pt must have life expectancy of > 6 mos. No evidence of current or prior CNS mets. Identification of HLA identical sibling donor. CTC PS of < / = 1. Age < / = 60. DLCO > 40% of expected; LVEF by MUGA or echo > / = 45%. No known hypersensitivity to E. coli-derived protducts. No uncontrolled diabetes mellitus or actie serious infection. HIV negative. Not pregnant and non-nursing. No currently active 2nd malignancy other than non-melanoma skin cancers. Granulocytes > / = 1,500; PLTS > / = 100,000; Calc Cr Cl > / = 40 mL/min; AST < / = 3 x ULN; total bili < / = 2 x ULN and u-HCG or serum HCG negative.