Use of CFU-GM assay for prediction of human maximum tolerated dose of a new antitumoral drug: Yondelis™ (ET-743)

Toxicology in Vitro

Volumn 17, Issue 5-6, 2003, Pages 671-674

  Gómez, Susana G ^a   Bueren, Juan A ^b   Faircloth, Glynn ^c   Albella, Beatriz ^b  

^a PHARMAMAR S A   (Spain)

^b CIEMAT   (Spain)

^c PharmaMar USA Inc   (United States)

Author keywords

Antitumoral drugs; CFU GM assay; Hematotoxicity

Indexed keywords

ANTINEOPLASTIC AGENT; TRABECTEDIN;

ANIMAL MODEL; BLOOD TOXICITY; COLONY FORMING UNIT GM; CONFERENCE PAPER; CONTINUOUS INFUSION; CONTROLLED STUDY; DRUG INFUSION; DRUG SENSITIVITY; EXPERIMENTAL MODEL; HUMAN; HUMAN CELL; MAXIMUM TOLERATED DOSE; MOUSE; NONHUMAN; PREDICTION; PROMYELOCYTE;

ANIMALIA; MURINAE;

EID: 0242361622     PISSN: 08872333     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0887-2333(03)00139-5     Document Type: Conference Paper

References (12)

1. Albella B., Segovia J.C., Guenechea G., Pragnell I.A., Bueren J.A. Preserved long-term repopulation and differentiation properties of hematopoietic graftas subjected to ex vivo expansion with stem cell factor and interleukin 11. Transplantation. 67:1999;1348-1357.
2. Delaloge S., Yovine A., Taamma A., Riofrio M., Brain E., Raymond E., Cottu P., Goldwasser F., Jimeno J., Misset J.L., Marty M., Cvitkovic E. Ecteinascidin-743: a marine-derived compound in advanced, pretreated sarcoma patients - preliminary evidence of activity. Journal of Clinical Oncology. 19:2001;1248-1255.
3. Jimeno J.M., Faircloth G.T., Cameron L., Meely K., Vega E., Gomez A., Sousa-Faro J.M.F., Rinehart K. Progress in the acquisition of new marine-derived anticancer compounds: development of Ecteinascidin-743 (ET-743). Drugs of the Future. 21:1996;1155-1165.
4. Jin S., Gorfajn B., Faircloth G., Scotto K.W., 2000. Ecteinascidin 743, a transcription-targeted chemotherapeutic that inhibits MDR1 activation. Proceedings of the National Academiy of Science of the United State of America 97, 6775-6779.
5. Parchment R.E., Huang M., Erickson-Miller C.L. Roles for in vitro myelotoxicity tests in preclinical drug development and clinical trial planning. Toxicologic Pathology. 21:1993;241-250.
6. Parchment R.E., Volpe D.A., LoRusso P.M., Erickson-Miller C.L., Murphy M.J., Grieshaber C.K. In vivo-in vitro correlation of myelotoxicity of 9-methoxypyrazoloacridine (NSC-366140m PD115934) to myeloid and erythroid hematopoeitic progenitors from human, murine and canine marrow. Journal of the National Cancer Institute. 86:1994;273-280.
7. Parchment R.E. Alternative testing systems for evaluating noncarcinogenic, hematologic toxicity. Environmental Health Perspectives. 106(Suppl 2):1998;541-557.
8. Pessina A., Albella B., Bueren J., Brantom P., Casati S., Gribaldo L., Croera C., Gagliardi G., Foti P., Parchment R., Parent-Massin D., Sibiril Y., Van Den Heuvel R. Prevalidation of a model for predicting acute neutropenia by colony forming unit granulocyte/macrophage (CFU-GM) assay. Toxicology In Vitro. 15:2001;729-740.
9. Pommier Y., Kohlhagen G., Bailly C., Waring M., Mazumder A., Kohn K.W. DNA sequence- and structure-selective alkilation of guanine N2 in the DNA minor groove by Ecteinascidin 743, a potent antitumor compound from the caribbean tunicate Ecteinascidin turbinate. Biochemistry. 35:1996;13303-13309.
10. Taamma A., Misset J.L., Riofrio M., Guzman C., Brain E., Lopez-Lázaro L., Rosing H., Jimeno J.M., Cvitkovic E. Phase I and pharmacokinetic study of ecteinascidin-743, a new marine compound, administered as a 24-h continuous infusion in patients with solid tumors. Journal of Clinical Oncology. 19:2001;1256-1265.
11. Takebayashi Y., Pourquier P., Zimonjic D.B., Nakayama K., Emmert S., Ueda T., Urasaki Y., Kanzaki A., Akiyama S.I., Popescu N., Kraemer K.H., Pommier Y. Antiproliferative activity of ecteinascidin 743 is dependent upon transcription-coupled nucleotide-excision repair. Nature Medicine. 7:2001;961-966.
12. van Kesteren C., Cvitkovic E., Taamma A., Lopez-Lázaro L., Jimeno J.M., Guzmán C., Matht R.A., Schellens J.H., Misset J.L., Brain E., Hillebrand M.J., Rosing H., Beijnen J.H. Pharmacokinetics and pharmacodynamics of the novel marine-derived anticancer agent ecteinascidin 743 in a phase I dose-finding study. Clinical Cancer Research. 6:2000;4725-4732.