Phase I study of gemcitabine (difluorodeoxycytidine) in children with relapsed on refractory leukemia (CCG-0955): A report from the children's cancer group

Leukemia and Lymphoma

Volumn 43, Issue 10, 2002, Pages 1945-1950

  Steinherz, P G ^a   Seibel, N L ^b   Ames, M M ^c   Avramis, V I ^d   Krailo, M D ^e   Liu Mares, W ^f   Reid, J M ^c   Safgren, S L ^c   Reaman, G H ^b  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^c MAYO CLINIC   (United States)

^d CHILDREN S HOSPITAL LOS ANGELES   (United States)

^e UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^f CHILDREN S ONCOLOGY GROUP   (United States)

Author keywords

Children's cancer group; Gemcitabine; HPCL; Relapsed or refractory leukemia

Indexed keywords

CYCLOPHOSPHAMIDE; GEMCITABINE; GEMCITABINE TRIPHOSPHATE; DEOXYCYTIDINE; DRUG DERIVATIVE;

ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ARTICLE; BLAST CELL; BLOOD CELL COUNT; BRONCHOSPASM; CANCER RECURRENCE; CELL LEVEL; CHILD; CHILDHOOD LEUKEMIA; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG ACTIVITY; DRUG CLEARANCE; DRUG HALF LIFE; DRUG METABOLISM; DRUG RESPONSE; FEMALE; FEVER; HEMATURIA; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HYPERBILIRUBINEMIA; HYPOTENSION; LIVER TOXICITY; LUNG TOXICITY; MALE; MAXIMUM TOLERATED DOSE; MYALGIA; NAUSEA AND VOMITING; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SEX DIFFERENCE; BIOTRANSFORMATION; CHEMICALLY INDUCED DISORDER; HALF LIFE TIME; INFANT; LEUKEMIA; LIVER DISEASE; METABOLIC CLEARANCE RATE; METHODOLOGY; PRESCHOOL CHILD; SALVAGE THERAPY;

ADOLESCENT; BIOTRANSFORMATION; CHILD; CHILD, PRESCHOOL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DEOXYCYTIDINE; FEMALE; HALF-LIFE; HUMANS; INFANT; LEUKEMIA; LIVER DISEASES; MALE; MAXIMUM TOLERATED DOSE; METABOLIC CLEARANCE RATE; SALVAGE THERAPY;

EID: 0036784821     PISSN: 10428194     EISSN: None     Source Type: Journal    
DOI: 10.1080/1042819021000015880     Document Type: Article

References (16)

1. Lund, B., Kristjansen, P.E.G. and Hansen, H.H. (1993) "Clinical and preclinical activity of 2′,2′-difluorodeoxycytidine (gemcitabine)", Cancer Treatment Reviews 19, 45-55.
2. Kaye, S.B. (1994) "Gemcitabine: Current status phase I and II trials", Journal of Clinical Oncology 12, 1527-1531.
3. Hertel, L.W., Boder, G.B., Kroin, J.S., Rinzel, S.M., Poore, G.A., Todd, G.C. and Grindley, G.B. (1990) "Evaluation of the antitumor activity of gemcitabine (2′,2′-difluoro-2′-deoxycytidine)", Cancer Research 50, 4417-4422.
4. Braakhuis, B.J., Van Dongen, G.A., Vermorken, J.B. and Snow, G.B. (1991) "Preclinical in vivo activity of 2′,2′-difluorodeoxy-cytidine (gemcitabine) against human head and neck cancer", Cancer Research 51, 211-214.
5. Ruiz van Haperen, V.W.T., Veerman, G., Vermorken, J.B. and Peters, G.J. (1994) "Improved antitumor effect of 2′,2′-difluoro-deoxycytidine (gemcitabine) in murine colon carcinomas when administered as continuous infusion", Proceedings of the American Association for Cancer Research 35, 447.
6. Abbruzzese, J.L., Grunewald, R., Weeks, E.A., Gravel, D., Adams, T., Nowak, B., Mineishi, S., Tarassoff, P., Satterlee, W., Raber, M.N. and Plunkett, W. (1991) "A phase I clinical, plasma, and cellular pharmacology study of gemcitabine", Journal of Clinical Oncology 9, 491-498.
7. Grunewald, R., Kantarjian, H., Du, M., Faucher, K., Tarassoff, P. and Plunkett, W. (1992) "Gemcitabine in Leukemia: A phase I clinical, plasma, and cellular pharmacology study", Journal of Clinical Oncology 10, 406-413.
8. Fosella, F., Abbruzzese, J., Pang, A., Gravel, D., Tarassoff, P., Lippman, S., Raber, M. and Hong, W.K. (1993) "Phase I studies of gemcitabine", European Journal of Cancer 29 (Suppl. 6), s119.
9. Shephard, F., Cormier, Y., Burkes, R., Crump, M., Feld, R. and Strack, T. (1995) "Modified continual reassessment methodology: A superior way to assess toxicity in a phase I study of gemcitabine and cisplatin for non-small cell lung cancer", Proceedings of the American Society of Clinical Oncology 14, 358.
10. Allerheiligen, S., Johnson, R., Hatcher, B., Freeman, K., Tarassoff, P., Voi, M. and Door, A. (1994) "Gemcitabine pharmacokinetics are influenced by gender, body surface area and duration of infusion", Proceedings of the American Society of Clinical Oncology 13, 136.
11. Freeman, K.B., Anliker, S., Hamilton, M., Osbourne, D., Dhahir, P.H., Nelson, R. and Allerheiligen, S.R. (1995) "Validated assays for the determination of gemcitabine in human plasma and urine using high-performance liquid chromatography with ultraviolet detection", Journal of Chromatography Biomedical Applications 665, 171-181.
12. Avramis, V.I., Biener, R., Krailo, M., Finkelstein, J., Ettinger, L., Willoughby, M., Siegel, S.E. and Holcenberg, J.S. (1987) "Biochemical pharmacology of high-dose 1-beta-D-arabinofurano-sylcytosine in childhood acute leukemia", Cancer Research 47, 6786-6792.
13. Gandhi, V., Huang, P., Xu, Y.Z., Heinemann, V. and Plunkett, W. (1991) "Metabolism and action of 2′,2′-difluorodeoxycytidine: Self-potentiation of cytotoxicity", Advances in Experimental Medicine and Biology 309A, 125-130.
14. Grunewald, R., Abbruzzese, J.L., Tarassoff, P. and Plunkett, W. (1991) "Saturation of 2′,2′-difluorodeoxycytidine 5′ triphosphate accumulation by mononuclear cells during a phase I trial of gemcitabine", Cancer Chemotherapy and Pharmacology 27, 258-262.
15. Grunewald, R., Kantaijian, H., Keating, M.J., Abbruzzese, J., Tarassoff, P. and Plunket, W. (1990) "Pharmacologically directed design of the dose rate and schedule of 2′,2′-difluorodeoxycytidine (Gemcitabine) administration in leukemia", Cancer Research 50, 6823-6826.
16. Pavlakis, N., Bell, D.R., Millward, M.J. and Levi, J.A. (1997) "Fatal pulmonary toxicity resulting from treatment with gemcitabine", Cancer 80, 286-291.