Phase 1 study of XL119, a rebeccamycin analog, in patients with refractory hematologic malignancies

Gautam Borthakur, Yesid Alvarado, Farhad Ravandi-Kashani, Jorge Cortes, Zeev Estrov, Stefan Faderl, Percy Ivy, Carlos Bueso-Ramos, B. Nebiyou Bekele, Francis Giles

Research output: Contribution to journalArticlepeer-review

9 Scopus citations


BACKGROUND. XL119 is a water-soluble derivative of rebeccamycin with dose-dependent myelosuppression as dose-limiting toxicity in phase 1 studies of solid tumors. A phase 1 study was conducted to determine the maximum tolerated dose and toxicities of XL119 in patients with advanced myelodysplastic syndrome and relapsed or refractory acute leukemias. METHODS. Thirty-one patients were treated at 7 dose levels ranging from 140 to 260 mg/m2/daily times 5 in a 21-day cycle. Consenting patients had correlative biologic parameters studied. RESULTS. Dose-limiting toxicity was grade 3/4 mucositis. The recommended phase 2 dose in hematologic malignancies is 240 mg/m 2/daily times 5 in a 21-day cycle. Clinically significant reduction in bone marrow blasts were seen in 5 patients and additional patients had reductions in peripheral blood blasts. However, the responses were transient. Changes of plasma vascular endothelial growth factor levels from Day 1 to Day 7 correlated negatively with changes in peripheral blood blasts from Day 1 to Day 7. CONCLUSIONS. Further assessment of XL119 in combination with other agents in patients with acute leukemias and high-risk myelodysplastic syndrome is warranted.

Original languageEnglish (US)
Pages (from-to)360-366
Number of pages7
Issue number2
StatePublished - Jul 15 2008
Externally publishedYes


  • Leukemia
  • Phase 1
  • Rebeccamycin analog
  • XL119

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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