Phase I dose-escalation trial of clofarabine followed by escalating doses of fractionated cyclophosphamide in children with relapsed or refractory acute leukemias

Pediatric Blood and Cancer

Volumn 59, Issue 7, 2012, Pages 1252-1258

  Abd Elmoneim, Abeer ^a   Gore, Lia ^b   Ricklis, Rebecca M ^a   Boklan, Jessica ^c   Cooper, Todd ^d   Narendran, Aru ^e   Rolla, Katherine ^f   Scott, Tammy ^a   Arceci, Robert J ^a  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^c Center for Cancer and Blood disorders   (United States)

^d EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e Alberta Children's Hospital   (United States)

^f MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Clofarabine; Cyclophosphamide; Pediatric leukemias; Phase I; Relapsed refractory

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ALKALINE PHOSPHATASE; ALLOPURINOL; ASPARTATE AMINOTRANSFERASE; CLOFARABINE; CORTICOSTEROID; CREATININE; CYCLOPHOSPHAMIDE; DNA; HYDROCORTISONE; PARACETAMOL;

ACUTE LYMPHOBLASTIC LEUKEMIA; ACUTE MYELOBLASTIC LEUKEMIA; ADOLESCENT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BRADYCARDIA; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER REGRESSION; CANCER SURGERY; CARDIOPULMONARY INSUFFICIENCY; CHILD; CLINICAL ARTICLE; CONFUSION; COUGHING; CREATININE BLOOD LEVEL; DNA DAMAGE; DRUG DOSE ESCALATION; FEMALE; HEPATORENAL SYNDROME; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; HYPOTENSION; HYPOXIA; KIDNEY FAILURE; LEUKEMIA RELAPSE; MALE; MAXIMUM TOLERATED DOSE; MYOSITIS; NAUSEA AND VOMITING; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PLEURA EFFUSION; PRESCHOOL CHILD; PRIORITY JOURNAL; RESTRICTIVE CARDIOMYOPATHY; SCHOOL CHILD; SIDE EFFECT; SINUS TACHYCARDIA; TACHYCARDIA; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE;

ACUTE DISEASE; ADENINE NUCLEOTIDES; ADOLESCENT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ARABINONUCLEOSIDES; CHILD; CHILD, PRESCHOOL; CYCLOPHOSPHAMIDE; DNA DAMAGE; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LEUKEMIA; LEUKEMIA, MYELOID, ACUTE; MALE; MAXIMUM TOLERATED DOSE; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; RECURRENCE; YOUNG ADULT;

EID: 84867385188     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.24264     Document Type: Article

References (27)

1. Pui CH, Carroll WL, Meshinchi S, et al. Biology, risk stratification, and therapy of pediatric acute leukemias: An update. J Clin Oncol 2011; 29: 551- 565.
2. Gaynon PS, Angiolillo AL, Carroll WL, et al. Long-term results of the children's cancer group studies for childhood acute lymphoblastic leukemia 1983-2002: A Children's Oncology Group Report. Leukemia 2010; 24: 285- 297.
3. Silverman LB, Stevenson KE, O'Brien JE, et al. Long-term results of Dana-Farber Cancer Institute ALL Consortium protocols for children with newly diagnosed acute lymphoblastic leukemia (1985-2000). Leukemia 2010; 24: 320- 334.
4. Ko RH, Ji L, Barnette P, et al. Outcome of patients treated for relapsed or refractory acute lymphoblastic leukemia: A Therapeutic Advances in Childhood Leukemia Consortium study. J Clin Oncol 2010; 28: 648- 654.
5. Zwaan CM, Reinhardt D, Zimmerman M, et al. Salvage treatment for children with refractory first or second relapse of acute myeloid leukaemia with gemtuzumab ozogamicin: Results of a phase II study. Br J Haematol 2010; 148: 768- 776.
6. Kantarjian HM, Jeha S, Gandhi V, et al. Clofarabine: Past, present, and future. Leuk Lymphoma 2007; 48: 1922- 1930.
7. Parker WB, Shaddix SC, Rose LM, et al. Comparison of the mechanism of cytotoxicity of 2-chloro-9-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl)adenine, 2-chloro-9-(2-deoxy-2-fluoro-beta-D-ribofuranosyl)adenine, and 2-chloro-9-(2-deoxy-2, 2-difluoro-beta-D-ribofuranosyl)adenine in CEM cells. Mol Pharmacol 1999; 55: 515- 520.
8. Lech-Maranda E, Korycka A, Robak T. Clofarabine as a novel nucleoside analogue approved to treat patients with haematological malignancies: Mechanism of action and clinical activity. Mini Rev Med Chem 2009; 9: 805- 812.
9. Yamauchi T, Nowak BJ, Keating MJ, et al. DNA repair initiated in chronic lymphocytic leukemia lymphocytes by 4-hydroperoxycyclophosphamide is inhibited by fludarabine and clofarabine. Clin Cancer Res 2001; 7: 3580- 3589.
10. Chang CH, Cheng YC. Effects of deoxyadenosine triphosphate and 9-beta-D-arabinofuranosyl-adenine 5'-triphosphate on human ribonucleotide reductase from Molt-4F cells and the concept of "self-potentiation". Cancer Res 1980; 40: 3555- 3558.
11. Zhenchuk A, Lotfi K, Juliusson G, et al. Mechanisms of anti-cancer action and pharmacology of clofarabine. Biochem Pharmacol 2009; 78: 1351- 1359.
12. Genini D, Budihardjo I, Plunkett W, et al. Nucleotide requirements for the in vitro activation of the apoptosis protein-activating factor-1-mediated caspase pathway. J Biol Chem 2000; 275: 29- 34.
13. Takahashi T, Shimizu M, Akinaga S. Mechanisms of the apoptotic activity of Cl-F-araA in a human T-ALL cell line, CCRF-CEM. Cancer Chemother Pharmacol 2002; 50: 193- 201.
14. Karp JE, Ricklis RM, Balakrishnan K, et al. A phase 1 clinical-laboratory study of clofarabine followed by cyclophosphamide for adults with refractory acute leukemias. Blood 2007; 110: 1762- 1769.
15. Calvert AH, Newell DR, Gumbrell LA, et al. Carboplatin dosage: Prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989; 7: 1748- 1756.
16. Sung RY, Huang GY, Shing MK, et al. Echocardiographic evaluation of cardiac function in paediatric oncology patients treated with or without anthracycline. Int J Cardiol 1997; 60: 239- 248.
17. Cheson BD, Bennett JM, Kopecky KJ, et al. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 2003; 21: 4642- 4649.
18. Faderl S, Gandhi V, O'Brien S, et al. Results of a phase 1-2 study of clofarabine in combination with cytarabine (ara-C) in relapsed and refractory acute leukemias. Blood 2005; 105: 940- 947.
19. Faderl S, Ravandi F, Huang X, et al. A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. Blood 2008; 112: 1638- 1645.
20. Jeha S, Gandhi V, Chan KW, et al. Clofarabine, a novel nucleoside analog, is active in pediatric patients with advanced leukemia. Blood 2004; 103: 784- 789.
21. Jeha S, Gaynon PS, Razzouk BI, et al. Phase II study of clofarabine in pediatric patients with refractory or relapsed acute lymphoblastic leukemia. J Clin Oncol 2006; 24: 1917- 1923.
22. Kantarjian H, Gandhi V, Cortes J, et al. Phase 2 clinical and pharmacologic study of clofarabine in patients with refractory or relapsed acute leukemia. Blood 2003; 102: 2379- 2386.
23. Jeha S, Razzouk B, Rytting M, et al. Phase II study of clofarabine in pediatric patients with refractory or relapsed acute myeloid leukemia. J Clin Oncol 2009; 27: 4392- 4397.
24. Hijiya N, Gaynon P, Barry E, et al. A multi-center phase I study of clofarabine, etoposide and cyclophosphamide in combination in pediatric patients with refractory or relapsed acute leukemia. Leukemia 2009; 23: 2259- 2264.
25. Locatelli F, Testi AM, Bernardo ME, et al. Clofarabine, cyclophosphamide and etoposide as single-course re-induction therapy for children with refractory/multiple relapsed acute lymphoblastic leukaemia. Br J Haematol 2009; 147: 371- 378.
26. Steinherz PG, Shukla N, Kobos R, et al. Remission re-induction chemotherapy with clofarabine, topotecan, thiotepa, and vinorelbine for patients with relapsed or refractory leukemia. Pediatr Blood Cancer 2010; 54: 687- 693.
27. Faderl S. Clofarabine plus cytarabine compared to cytarabine alone in older patients with relapsed or refractory (R/R) acute myelogenous leukemia (AML): Results from the phase III CLASSIC 1 trial. J Clin Oncol 2011; 29.