Phase I trial of lenalidomide in pediatric patients with recurrent, refractory, or progressive primary CNS tumors: Pediatric Brain Tumor Consortium Study PBTC-018

Journal of Clinical Oncology

Volumn 29, Issue 3, 2011, Pages 324-329

  Warren, Katherine E ^a   Goldman, Stewart ^a   Pollack, Ian F ^a   Fangusaro, Jason ^a   Schaiquevich, Paula ^a   Stewart, Clinton F ^a   Wallace, Dana ^a   Blaney, Susan M ^a   Packer, Roger ^a   MacDonald, Tobey ^a   Jakacki, Regina ^a   Boyett, James M ^a   Kun, Larry E ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

LENALIDOMIDE; THALIDOMIDE;

ADOLESCENT; ADULT; ANEMIA; ARTICLE; ASTROCYTOMA; BONE MARROW SUPPRESSION; BRAIN TUMOR; CANCER RECURRENCE; CENTRAL NERVOUS SYSTEM TUMOR; CHILD; CONSTIPATION; DIARRHEA; DIZZINESS; DOSE TIME EFFECT RELATION; DRUG DOSE ESCALATION; ELECTROLYTE DISTURBANCE; FATIGUE; FEMALE; GLIOMA; HEADACHE; HEART INFARCTION; HUMAN; HYPOKALEMIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MAXIMUM PERMISSIBLE DOSE; MAXIMUM PLASMA CONCENTRATION; METABOLIC DISORDER; MULTIPLE CYCLE TREATMENT; MUSCLE CRAMP; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADMINISTRATION, ORAL; ADOLESCENT; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CENTRAL NERVOUS SYSTEM NEOPLASMS; CHILD; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; RECURRENCE; THALIDOMIDE; YOUNG ADULT;

EID: 79951986245     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.31.3601     Document Type: Article

References (27)

1. Central Brain Tumor Registry of the United States: Statistical report: Primary brain tumors in the United States, 2000-2004. http://www.cbtrus.org/ reports/2007-2008/2007report.pdf
2. National Cancer Institute: SEER Cancer Statistics Review, 1975-2004. Bethesda, MD, National Cancer Institute, 2007
3. Zhu D, Corral LG, Fleming YW, et al: Immunomodulatory drugs Revlimid (lenalidomide) and CC-4047 induce apoptosis of both hematological and solid tumor cells through NK cell activation. Cancer Immunol Immunother 57:1849-1859, 2008
4. Lu L, Payvandi F, Wu L, et al: The anti-cancer drug lenalidomide inhibits angiogenesis and metastasis via multiple inhibitory effects on endothelial cell function in normoxic and hypoxic conditions. Microvasc Res 77:78-86, 2009
5. Hideshima T, Anderson K: Preclinical studies of novel targeted therapies. Hematol Oncol Clin North Am 21:1071-1091, 2007 (Pubitemid 350051352)
6. Hayashi T, Hideshima T, Akiyama M, et al: Molecular mechanisms whereby immunomodulatory drugs activate natural killer cells: Clinical application. Br J Haematol 128:192-203, 2005
7. LeBlanc R, Hideshima T, Catley LP, et al: Immunomodulatory drug costimulates T cells via the B7-CD28 pathway. Blood 103:1787-1790, 2004 (Pubitemid 38268973)
8. Wiernik PH, Lossos IS, Tuscano JM, et al: Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol 26:4952-4957, 2008
9. Amato RJ, Hernandez-McClain J, Saxena S, et al: Lenalidomide therapy for metastatic renal cell carcinoma. Am J Clin Oncol 31:244-249, 2008
10. Fine HA, Kim L, Albert PS, et al: A phase I trial of lenalidomide in patients with recurrent primary central nervous system tumors. Clin Cancer Res 13:7101-7106, 2007 (Pubitemid 350276894)
11. Crane E, List A: Lenalidomide: An immunomodulatory drug. Future Oncol 1:575-583, 2005
12. Vallet S, Palumbo A, Raje N, et al: Thalidomide and lenalidomide: Mechanism-based potential drug combinations. Leuk Lymphoma 49:1238-1245, 2008 (Pubitemid 352015786)
13. Patel PH, Kondagunta GV, Schwartz L, et al: Phase II trial of lenalidomide in patients with metastatic renal cell carcinoma. Invest New Drugs 26:273-276, 2008
14. Zhang MM, Chan JK, Husain A, et al: Safety and efficacy of lenalidomide (Revlimid) in recurrent ovarian and primary peritoneal carcinoma. Gynecol Oncol 105:194-198, 2007 (Pubitemid 46441459)
15. Miller AA, Case D, Harmon M, et al: Phase I study of lenalidomide in solid tumors. J Thorac Oncol 2:445-449, 2007 (Pubitemid 47181700)
16. Choueiri TK, Dreicer R, Rini BI, et al: Phase II study of lenalidomide in patients with metastatic renal cell carcinoma. Cancer 107:2609-2616, 2006 (Pubitemid 44845615)
17. Sharma RA, Steward WP, Daines CA, et al: Toxicity profile of the immunomodulatory thalidomide analogue, lenalidomide: Phase I clinical trial of three dosing schedules in patients with solid malignancies. Eur J Cancer 42:2318-2325, 2006 (Pubitemid 44307625)
18. List A, Dewald G, Bennett J, et al: Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med 355:1456-1465, 2006 (Pubitemid 44511560)
19. Bartlett JB, Michael A, Clarke IA, et al: Phase I study to determine the safety, tolerability and immunostimulatory activity of thalidomide analogue CC-5013 in patients with metastatic malignant melanoma and other advanced cancers. Br J Cancer 90:955-961, 2004 (Pubitemid 38495811)
20. Knight R, DeLap R, Zeldis J: Lenalidomide and venous thrombosis in multiple myeloma. N Engl J Med 354:2079-2080, 2006
21. Piantadosi S, Fisher JD, Grossman S: Practical implementation of a modified continual reassessment method for dose-finding trials. Cancer Chemother Pharmacol 41:429-436, 1998 (Pubitemid 28140705)
22. Tohnya TM, Hwang K, Lepper ER, et al: Determination of CC-5013, an analogue of thalidomide, in human plasma by liquid chromatographymass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 811:135-141, 2004 (Pubitemid 39446758)
23. Beal S, Sheiner L: NONMEM User's Guide. San Francisco, CA, University of California, San Francisco, 1998
24. Richardson PG, Schlossman RL, Weller E, et al: Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. Blood 100:3063-3067, 2002 (Pubitemid 35217050)
25. Berg S, Russell H, Cairo M, et al: Phase I and pharmacokinetic (PK) study of lenalidomide (LEN) in pediatric patients with relapsed/refractory solid tumors or myelodysplastic syndrome (MDS): A Children's Oncology Group phase I consortium study. J Clin Oncol 27:525s, 2009 (suppl 15s; abstr 10023)
26. Nicholson HS, Kretschmar CS, Krailo M, et al: Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: A report from the Children's Oncology Group. Cancer 110:1542-1550, 2007 (Pubitemid 47463069)
27. Anderson K: Lenalidomide and thalidomide: Mechanisms of action - Similarities and differences. Semin Hematol 42:S3-S8, 2005 (suppl)