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The Principal Investigator left the institution.
Sponsor study identifier
interventional
1
1 country
1
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2017
Actual (reported)Study Completion
August 2017
Actual (reported)There is currently no standard treatment for patients with neuro-epithelial (brain) or other solid tumors in another part of the body who do not have adequate suitable autologous hematopoietic progenitor cells available and/or whose disease has relapsed after standard treatment. Allogeneic Hematopoietic Progenitor Cell Transplant may be a consideration for treatment of patients with recurrent chemo-responsive malignant (high grade) neuro-epithelial and other solid tumors or those who do not have suitable autologous hematopoietic progenitor cell availability. The procedure in which your own blood stem cells are transplanted to you is called an autologous (from your own) progenitor cell transplant and when cells from a matched donor are transfused is called an allogeneic progenitor cell transplant. The study is being conducted to evaluate the safety and effectiveness of a combination of drugs followed by an allogeneic hematopoietic progenitor cell transplant (HPCT). This treatment regimen is experimental in that although the individual drugs are commonly used to treat your disease, the specific combination used in this protocol followed by the transplant is experimental.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 7, 2016
Actual (reported)January 12, 2016
Actual (reported)August 2017
Actual (reported)August 2017
Actual (reported)Progression-Free Survival
Six months post-transplant
Overall Survival
One year post-transplant
Transplant Related Mortality
Day +100 post-transplant
Engraftment
Within 100 days post-transplant
Regimen Related Toxicity
Within one year post-transplant
Time to Immune Reconstitution
Within one year post-transplant
Feasibility of Taqman® Low Density Arrays (TLDA)
Prior to stem cell infusion to one year post-transplant, at specified intervals.
Alemtuzumab Assay
Ten days prior to stem cell infusion to 28 days post-transplant, at specified intervals
Matched Unrelated Donor HSCT (minimum 9/10 human leukocyte antigen \[HLA\] match) OR Matched Related Donor HSCT (10/10 HLA match). Conditioning regimen begins 12 days prior to stem cell infusion and includes the following drugs: Keratinocyte Growth Factor Alemtuzumab Thiotepa Etoposide Melphalan Fludarabine Tacrolimus (Cyclosporine A may be substituted for Tacrolimus) Mycophenolate mofetil
Allogeneic hematopoietic stem cell transplant (HSCT) following thiotepa-based marrow ablative chemotherapy (MAC) for children with high-grade and/or recurrent neuro-epithelial and other solid tumors.
KGF 60 mcg/kg IV: 6 doses
The Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Smith MA, Seibel NL, Altekruse SF, Ries LA, Melbert DL, O'Leary M, Smith FO, Reaman GH. Outcomes for children and adolescents with cancer: challenges for the twenty-first century. J Clin Oncol. 2010 May 20;28(15):2625-34. doi: 10.1200/JCO.2009.27.0421. Epub 2010 Apr 19.
Chow KH, Gottschalk S. Cellular immunotherapy for high-grade glioma. Immunotherapy. 2011 Mar;3(3):423-34. doi: 10.2217/imt.10.110.
Kris M Mahadeo, MD,MPH
Children's Hospital at Montefiore
1 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2016
First Posted
January 12, 2016
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Alemtuzumab 12 mg/m2 IV: 2 doses (not given if matched related donor is 10/10 HLA matched sibling donor)
Etoposide 100 mg/m2 IV: 3 doses
Fludarabine 30 mg/m2 IV: 3 doses
Tacrolimus 0.05 mg/kg/day IV (Cyclosporine may be substituted for Tacrolimus): Start Day -2, begin taper on Day +100, discontinue on Day +180
Cyclosporine A dosed as follows: Age ≤ 6 years: 6 mg/kg/day IV in divided doses (e.g. 2 mg/kg every 8 hours) OR Age \> 6 years: 3 mg/kg/day IV in divided doses (1.5 mg/kg every 12 hours): Start Day -2, begin taper on Day +100, discontinue on Day +180
Mycophenolate mofetil 15 mg/kg every 8 hours oral or IV: Start Day 0 (4-6 hours post stem cell infusion) to Day +40, then taper weekly until discontinuation on Day +90
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Takada S, Ito K, Sakura T, Hatsumi N, Sato M, Saito T, Shiozaki H, Matsushima T, Miyawaki S. Three AML patients with existing or pre-existing intracerebral granulocytic sarcomas who were successfully treated with allogeneic bone marrow transplantations. Bone Marrow Transplant. 1999 Apr;23(7):731-4. doi: 10.1038/sj.bmt.1701635.
Kasow KA, Handgretinger R, Krasin MJ, Pappo AS, Leung W. Possible allogeneic graft-versus-tumor effect in childhood melanoma. J Pediatr Hematol Oncol. 2003 Dec;25(12):982-6. doi: 10.1097/00043426-200312000-00016.
Ueno NT, Cheng YC, Rondon G, Tannir NM, Gajewski JL, Couriel DR, Hosing C, de Lima MJ, Anderlini P, Khouri IF, Booser DJ, Hortobagyi GN, Pagliaro LC, Jonasch E, Giralt SA, Champlin RE. Rapid induction of complete donor chimerism by the use of a reduced-intensity conditioning regimen composed of fludarabine and melphalan in allogeneic stem cell transplantation for metastatic solid tumors. Blood. 2003 Nov 15;102(10):3829-36. doi: 10.1182/blood-2003-04-1022. Epub 2003 Jul 24.
Ruggeri L, Capanni M, Urbani E, Perruccio K, Shlomchik WD, Tosti A, Posati S, Rogaia D, Frassoni F, Aversa F, Martelli MF, Velardi A. Effectiveness of donor natural killer cell alloreactivity in mismatched hematopoietic transplants. Science. 2002 Mar 15;295(5562):2097-100. doi: 10.1126/science.1068440.
Venstrom JM, Zheng J, Noor N, Danis KE, Yeh AW, Cheung IY, Dupont B, O'Reilly RJ, Cheung NK, Hsu KC. KIR and HLA genotypes are associated with disease progression and survival following autologous hematopoietic stem cell transplantation for high-risk neuroblastoma. Clin Cancer Res. 2009 Dec 1;15(23):7330-4. doi: 10.1158/1078-0432.CCR-09-1720. Epub 2009 Nov 24.
Aoyama Y, Yamamura R, Shima E, Nakamae H, Makita K, Kho G, Ohta K, Yamane T, Takubo T, Hino M. Successful treatment with reduced-intensity stem cell transplantation in a case of relapsed refractory central nervous system lymphoma. Ann Hematol. 2003 Jun;82(6):371-3. doi: 10.1007/s00277-003-0651-z. Epub 2003 Apr 29.
Varadi G, Or R, Kapelushnik J, Naparstek E, Nagler A, Brautbar C, Amar A, Kirschbaum M, Samuel S, Slavin S, Siegal T. Graft-versus-lymphoma effect after allogeneic peripheral blood stem cell transplantation for primary central nervous system lymphoma. Leuk Lymphoma. 1999 Jun;34(1-2):185-90. doi: 10.3109/10428199909083396.
Abdel-Azim H, Kapoor N, Mahadeo KM, Finlay JL. Graft versus tumor effect in the brain of a child with recurrent metastatic medulloblastoma. Pediatr Blood Cancer. 2015 Sep;62(9):1667-9. doi: 10.1002/pbc.25525. Epub 2015 Apr 20.
Ellman L, Katz DH, Green I, Paul WE, Benacerraf B. Mechanisms involved in the antileukemic effect of immunocompetent allogeneic lymphoid cell transfer. Cancer Res. 1972 Jan;32(1):141-8. No abstract available.
Symons HJ, Levy MY, Wang J, Zhou X, Zhou G, Cohen SE, Luznik L, Levitsky HI, Fuchs EJ. The allogeneic effect revisited: exogenous help for endogenous, tumor-specific T cells. Biol Blood Marrow Transplant. 2008 May;14(5):499-509. doi: 10.1016/j.bbmt.2008.02.013.
Maine GN, Mule JJ. Making room for T cells. J Clin Invest. 2002 Jul;110(2):157-9. doi: 10.1172/JCI16166. No abstract available.
Ahmed N, Ratnayake M, Savoldo B, Perlaky L, Dotti G, Wels WS, Bhattacharjee MB, Gilbertson RJ, Shine HD, Weiss HL, Rooney CM, Heslop HE, Gottschalk S. Regression of experimental medulloblastoma following transfer of HER2-specific T cells. Cancer Res. 2007 Jun 15;67(12):5957-64. doi: 10.1158/0008-5472.CAN-06-4309.
Perez-Martinez A, de Prada Vicente I, Fernandez L, Gonzalez-Vicent M, Valentin J, Martin R, Maxwell H, Sevilla J, Vicario JL, Diaz MA. Natural killer cells can exert a graft-vs-tumor effect in haploidentical stem cell transplantation for pediatric solid tumors. Exp Hematol. 2012 Nov;40(11):882-891.e1. doi: 10.1016/j.exphem.2012.07.004. Epub 2012 Jul 4.
Ash S, Gigi V, Askenasy N, Fabian I, Stein J, Yaniv I. Graft versus neuroblastoma reaction is efficiently elicited by allogeneic bone marrow transplantation through cytolytic activity in the absence of GVHD. Cancer Immunol Immunother. 2009 Dec;58(12):2073-84. doi: 10.1007/s00262-009-0715-6. Epub 2009 May 13.
Lang P, Pfeiffer M, Muller I, Schumm M, Ebinger M, Koscielniak E, Feuchtinger T, Foll J, Martin D, Handgretinger R. Haploidentical stem cell transplantation in patients with pediatric solid tumors: preliminary results of a pilot study and analysis of graft versus tumor effects. Klin Padiatr. 2006 Nov-Dec;218(6):321-6. doi: 10.1055/s-2006-942256.
Jubert C, Wall DA, Grimley M, Champagne MA, Duval M. Engraftment of unrelated cord blood after reduced-intensity conditioning regimen in children with refractory neuroblastoma: a feasibility trial. Bone Marrow Transplant. 2011 Feb;46(2):232-7. doi: 10.1038/bmt.2010.107. Epub 2010 May 3.
Koscielniak E, Gross-Wieltsch U, Treuner J, Winkler P, Klingebiel T, Lang P, Bader P, Niethammer D, Handgretinger R. Graft-versus-Ewing sarcoma effect and long-term remission induced by haploidentical stem-cell transplantation in a patient with relapse of metastatic disease. J Clin Oncol. 2005 Jan 1;23(1):242-4. doi: 10.1200/JCO.2005.05.940. No abstract available.
Burdach S, van Kaick B, Laws HJ, Ahrens S, Haase R, Korholz D, Pape H, Dunst J, Kahn T, Willers R, Engel B, Dirksen U, Kramm C, Nurnberger W, Heyll A, Ladenstein R, Gadner H, Jurgens H, Go el U. Allogeneic and autologous stem-cell transplantation in advanced Ewing tumors. An update after long-term follow-up from two centers of the European Intergroup study EICESS. Stem-Cell Transplant Programs at Dusseldorf University Medical Center, Germany and St. Anna Kinderspital, Vienna, Austria. Ann Oncol. 2000 Nov;11(11):1451-62. doi: 10.1023/a:1026539908115.
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Capitini CM, Derdak J, Hughes MS, Love CP, Baird K, Mackall CL, Fry TJ. Unusual sites of extraskeletal metastases of Ewing sarcoma after allogeneic hematopoietic stem cell transplantation. J Pediatr Hematol Oncol. 2009 Feb;31(2):142-4. doi: 10.1097/MPH.0b013e31819146e5.
Hosono A, Makimoto A, Kawai A, Takaue Y. Segregated graft-versus-tumor effect between CNS and non-CNS lesions of Ewing's sarcoma family of tumors. Bone Marrow Transplant. 2008 Jun;41(12):1067-8. doi: 10.1038/bmt.2008.26. Epub 2008 Mar 10. No abstract available.
Kido A, Amano I, Honoki K, Tanaka H, Morii T, Fujii H, Yoshitani K, Tanaka Y. Allogeneic and autologous stem cell transplantation in advanced small round cell sarcomas. J Orthop Sci. 2010 Sep;15(5):690-5. doi: 10.1007/s00776-010-1504-y. Epub 2010 Oct 16. No abstract available.
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Ohta H, Hashii Y, Yoshida H, Kusuki S, Tokimasa S, Yoneda A, Fukuzawa M, Inoue N, Hara J, Kusafuka T, Ozono K. Allogeneic hematopoietic stem cell transplantation against recurrent rhabdomyosarcoma. J Pediatr Hematol Oncol. 2011 Jan;33(1):e35-8. doi: 10.1097/MPH.0b013e3181e7ddc5.
Donker AE, Hoogerbrugge PM, Mavinkurve-Groothuis AM, van de Kar NC, Boetes C, Hulsbergen-van de Kaa CA, Groot-Loonen JJ. Metastatic rhabdomyosarcoma cured after chemotherapy and allogeneic SCT. Bone Marrow Transplant. 2009 Jan;43(2):179-80. doi: 10.1038/bmt.2008.301. Epub 2008 Sep 1. No abstract available.
Baird K, Fry TJ, Steinberg SM, Bishop MR, Fowler DH, Delbrook CP, Humphrey JL, Rager A, Richards K, Wayne AS, Mackall CL. Reduced-intensity allogeneic stem cell transplantation in children and young adults with ultrahigh-risk pediatric sarcomas. Biol Blood Marrow Transplant. 2012 May;18(5):698-707. doi: 10.1016/j.bbmt.2011.08.020. Epub 2011 Sep 5.
Childs R, Chernoff A, Contentin N, Bahceci E, Schrump D, Leitman S, Read EJ, Tisdale J, Dunbar C, Linehan WM, Young NS, Barrett AJ. Regression of metastatic renal-cell carcinoma after nonmyeloablative allogeneic peripheral-blood stem-cell transplantation. N Engl J Med. 2000 Sep 14;343(11):750-8. doi: 10.1056/NEJM200009143431101.
Scott M, Lawrance J, Dennis M. Regression of a renal cell carcinoma following allogeneic peripheral blood stem cell transplant for acute myeloid leukaemia: evidence of a graft-versus-tumour effect without significant graft-versus-host disease. Br J Haematol. 2012 Oct;159(1):1. doi: 10.1111/j.1365-2141.2012.09238.x. Epub 2012 Jul 27. No abstract available.
Baek HJ, Han DK, Hwang TJ, Bae SH, Choi YD, Kook H. Long-term graft-versus-tumor effect following reduced intensity hematopoietic stem cell transplantation in a child with metastatic renal cell carcinoma. Pediatr Blood Cancer. 2012 Sep;59(3):583-5. doi: 10.1002/pbc.24074. Epub 2012 Jan 9.
Inaba H, Handgretinger R, Furman W, Hale G, Leung W. Allogeneic graft-versus-hepatoblastoma effect. Pediatr Blood Cancer. 2006 Apr;46(4):501-5. doi: 10.1002/pbc.20404.
Pappo AS, Anderson JR, Crist WM, Wharam MD, Breitfeld PP, Hawkins D, Raney RB, Womer RB, Parham DM, Qualman SJ, Grier HE. Survival after relapse in children and adolescents with rhabdomyosarcoma: A report from the Intergroup Rhabdomyosarcoma Study Group. J Clin Oncol. 1999 Nov;17(11):3487-93. doi: 10.1200/JCO.1999.17.11.3487.
Bowers DC, Gargan L, Weprin BE, Mulne AF, Elterman RD, Munoz L, Giller CA, Winick NJ. Impact of site of tumor recurrence upon survival for children with recurrent or progressive medulloblastoma. J Neurosurg. 2007 Jul;107(1 Suppl):5-10. doi: 10.3171/PED-07/07/005.
Primary Completion
August 2017
Actual (reported)Study Completion
August 2017
Actual (reported)Last Updated
August 17, 2017
Record last verified: 2017-06
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