Ifosfamide, carboplatin, and etoposide (ICE) reinduction chemotherapy in a large cohort of children and adolescents with recurrent/refractory sarcoma: The Children's Cancer Group (CCG) experience

Q3 · MEDICINE

Article

Author: Gregory Reaman ; Mark Krailo ; Patrick Van Winkle ; Barry Anderson ; Virginia Davenport ; Anne Angiolillo ; Ying-Kuen Cheung ; Mitchell S. Cairo

AbstractBackgroundThe prognosis for children with recurrent/refractory sarcomas is poor. We determined the overall response rate (ORR) and overall survival (OS) of children with recurrent/refractory sarcomas who were given ifosfamide, carboplatin, and etoposide (ICE) in three Children's Cancer Group (CCG) phase I/II trials.ProcedureChildren with recurrent/refractory sarcoma were treated with ifosfamide (1,800 mg/m2/day on day 0–4), carboplatin (400 mg/m2/day on day 0–1), etoposide (100 mg/m2/day on day 0–4) and either rhG‐CSF (10 μg/kg/day vs. 5 μg/kg/day, CCG‐0894, 71 patients), PIXY321 (500–1,000 μg/m2/day, CCG‐0924, 14 patients), or rhG‐CSF (5 μg/kg/day) and IL‐6 (2.5–5 μg/kg/day, CCG‐0931, 12 patients).ResultsNinety‐seven patients were evaluable for tumor response, 56 male and 41 female, median age 14.1 years (range 2.8–22.5 years). Tumor types were osteosarcoma (OTS) (n = 34), rhabdomyosarcoma (n = 27), Ewing sarcoma (EWS) (n = 21), soft tissue sarcoma‐not otherwise specified (n = 5), undifferentiated sarcoma (n = 6), fibrosarcoma (n = 2), peripheral primitive neuroectodermal tumor (n = 1), and extraosseous Ewing (n = 1). The ORR was 51% (27% complete response [CR]). OS at 1 and 2 years was 49% and 28%, respectively. Patients with CR or partial response (PR) had significantly increased 1‐ and 2‐year OS, 71% and 41%, respectively, (P < 0.001). Rhabdomyosarcoma patients with embryonal histology had significant improvement in 1‐ and 2‐year OS: 82% and 46%, respectively, compared with other histologies, (P < 0.005).ConclusionsThe ORR to ICE reinduction chemotherapy in children with recurrent/refractory sarcoma was 51%. OS of 1 and 2 years appeared significantly improved in patients who had CR or PR following ICE reinduction therapy or who had rhabdomyosarcoma with embryonal histology. © 2004 Wiley‐Liss, Inc.

15 Jun 2003·BloodQ1 · MEDICINE

Augmentation of umbilical cord blood (UCB) transplantation with ex vivo–expanded UCB cells: results of a phase 1 trial using the AastromReplicell System

Q1 · MEDICINE

Article

Author: Driscoll, Timothy A. ; Fu, Pingfu ; Burhop, Sue ; Waters-Pick, Barbara ; Goltry, Kristin ; Martin, Paul L. ; Douville, Judy ; Kurtzberg, Joanne ; Howrey, Richard ; Jaroscak, Jennifer ; Smith, Alan ; Chao, Nelson

AbstractAllogeneic stem cell transplantation with umbilical cord blood (UCB) cells is limited by the cell dose a single unit provides recipients. Ex vivo expansion is one strategy to increase the number of cells available for transplantation. Aastrom Biosciences developed an automated continuous perfusion culture device for expansion of hematopoietic stem cells (HSCs). Cells are expanded in media supplemented with fetal bovine serum, horse serum, PIXY321, flt-3 ligand, and erythropoietin. We performed a phase 1 trial augmenting conventional UCB transplants with ex vivo–expanded cells. The 28 patients were enrolled on the trial between October 8, 1997 and September 30, 1998. UCB cells were expanded in the device, then administered as a boost to the conventional graft on posttransplantation day 12. While expansion of total cells and colony-forming units (CFUs) occurred in all cases, the magnitude of expansion varied considerably. The median fold increase was 2.4 (range, 1.0-8.5) in nucleated cells, 82 (range, 4.6-266.4) in CFU granulocyte-macrophages, and 0.5 (range, 0.09-2.45) in CD34+ lineage negative (lin–) cells. CD3+ cells did not expand under these conditions. Clinical-scale ex vivo expansion of UCB is feasible, and the administration of ex vivo–expanded cells is well tolerated. Augmentation of UCB transplants with ex vivo–expanded cells did not alter the time to myeloid, erythroid, or platelet engraftment in 21 evaluable patients. Recipients of ex vivo–expanded cells continue to have durable engraftment with a median follow-up of 47 months (range, 41-51 months). A randomized phase 2 study will determine whether augmenting UCB transplants with ex vivo–expanded UCB cells is beneficial.

01 May 2003·Cytometry Part AQ4 · BIOLOGY

Flow cytometric characterization of perfused human bone marrow cultures: Identification of the major cell lineages and correlation with the CFU‐GM assay

Q4 · BIOLOGY

Article

Author: R. J. Richardson ; A. K. Smith ; R. J. Maher ; D. A. Brott ; C. R. Parrish

AbstractBackgroundProlific cultures of human bone marrow mononuclear cells (BM MNCs) were recently developed that include a full spectrum of hematopoietic and accessory cells, with the presence of autofluorescent cells indicating adequate cell expansion. However, phenotypic and functional clonogenic characterizations of the autofluorescent cells and the various other subpopulations present in these cultures have not been carried out.MethodsCells from a continuously perfused bioreactor inoculated with BM MNCs and cultured for 12 days in serum‐containing medium with PIXY321, erythropoietin, and with or without FLT3‐L were evaluated by using flow cytometry.ResultsTwo antibodies, CD71 and CD13, allowed the separation of the autofluorescent cells into two distinct populations. The CD71+CD13++ autofluorescent population contained the colony‐forming unit (CFU) fibroblast, and the CD71++CD13++ autofluorescent population contained macrophage/dendritic like cells. The CFU‐granulocyte/macrophage (CFU‐GM) could not be thoroughly evaluated with CD71 and CD13. However, the number of CD13+/++Lin− cells correlated with the number of CFU‐GM (r = 0.83), with approximately 1 CFU‐GM for every 30 CD13+/++Lin− cells.ConclusionsThe data showed that CD71 and CD13 antibodies separate the autofluorescent cells into two populations but do not separate hematopoietic cells into specific phenotypic populations. The data also showed that the number of CD13+/++Lin− cells correlated with the number of CFU‐GM. These data present the initial step toward detailed phenotypic analysis of ex vivo expanded human BM MNC cultures. Cytometry Part A 53A:22–27, 2003. © 2003 Wiley‐Liss, Inc.

100 Deals associated with Milodistim(Amgen, Inc.)

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Indication	Highest Phase	Country/Location	Organization	Date
Chemotherapy-induced damage	Phase 3	US	Amgen, Inc.	-
Chemotherapy-induced damage	Phase 3	CA	-	-
Neutropenia	Phase 3	US	Amgen, Inc.	-
Neutropenia	Phase 3	CA	-	-
Neutropenia	Phase 3	-	Wyeth AB	-
Thrombocytopenia	Phase 3	CA	-	-
Thrombocytopenia	Phase 3	US	Amgen, Inc.	-
Thrombocytopenia	Phase 3	-	Wyeth AB	-

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