A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors

Date de début de l'étude : 1 novembre 1998

Inclusion Criteria: Histologically confirmed high-risk or relapsed solid tumors or brain tumors, including: Metastatic or relapsed Ewing's sarcoma Metastatic or relapsed rhabdomyosarcoma Refractory Wilms' tumor Diffuse anaplastic Wilms' tumor Stage III or IV neuroblastoma Recurrent retinoblastoma Metastatic or relapsed germ cell tumors Metastatic or relapsed other soft tissue sarcomas Small cell ovarian sarcoma Metastatic or relapsed primitive neuroectodermal tumors of the bone Recurrent brain tumors Desmoplastic small round cell tumors Recurrent or metastatic chordomas Metastatic or relapsed hepatoblastoma Patients receive peripheral blood stem cell transplantation only if in complete remission or in very good partial remission with no disease progression Must have radiologic, nuclear image, or histologic verification of relapse Age 1 to 45 Performance status:Karnofsky 70-100% Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin count at least 10 g/dL Bilirubin less than 2 times upper limit of normal (ULN) SGOT or SGPT less than 2.5 times ULN Creatinine less than 2 times ULN Creatinine clearance greater than 70 mL/min Cardiac shortening fraction greater than 30% Cardiac ejection fraction greater than 45% At least 1 week since prior hematopoietic growth factor and recovered At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Recovered from any prior therapy Exclusion Criteria: Osteogenic sarcoma Less than 4 months Uncontrolled bleeding Congestive heart failure Uncontrolled hypertension Asthma Pregnant or nursing Uncontrolled metabolic disease Active severe infection Allergy to aminothiol compounds Prior bone marrow transplantation Other concurrent investigational agents