A phase II study of extended dose temozolomide and thalidomide in previously treated patients with metastatic melanoma

J Cancer Res Clin Oncol. 2006 Sep;132(9):611-6. doi: 10.1007/s00432-006-0114-8. Epub 2006 Jun 2.

Abstract

Purpose: To assess the efficacy and tolerability of extended dose temozolomide and continuous thalidomide in patients with advanced metastatic cutaneous melanoma.

Patients and methods: Eligibility criteria included adults with histologic diagnosis of metastatic melanoma with adequate organ function and performance status. Temozolomide (75 mg/m(2)/day) was administered for 6 weeks followed by a 2-week rest. Thalidomide (200 mg/day) was given for the first 2 weeks and increased by 100 mg/day at weekly intervals up to a maximum of 400 mg/day, if no toxicity. For patients older than 70 years, thalidomide was started at 100 mg/day and the dose was increased by 50 mg/day up to a maximum of 250 mg/day.

Results: Twenty-six extensively pretreated subjects, with poor prognostic factors, were entered into this study and included in all analyses. According to the RECIST criteria, one (4%) subject achieved a complete response (CR), two (8%) partial response (PR), and five (19%) stable disease (SD), for a response rate (CR + PR) of 12% [95% confidence interval (CI), 0-24.7%] and a clinical benefit (CR + PR + SD) of 31%. Median time to progression was 1.8 months (95% CI, 1.2-2.4 months) and median survival was 5.2 months (95% CI, 4.1-6.2 months).

Conclusions: The combination of temozolomide and thalidomide is well tolerated in patients with very advanced heavily pretreated metastatic melanoma. It has modest activity in this population with grave prognosis.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Dacarbazine / administration & dosage
  • Dacarbazine / adverse effects
  • Dacarbazine / analogs & derivatives*
  • Disease Progression
  • Dose-Response Relationship, Drug
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Humans
  • Male
  • Maximum Tolerated Dose
  • Melanoma / drug therapy*
  • Melanoma / pathology
  • Melanoma / secondary
  • Middle Aged
  • Skin Neoplasms / drug therapy*
  • Skin Neoplasms / pathology
  • Survival Rate
  • Temozolomide
  • Thalidomide / administration & dosage*
  • Thalidomide / adverse effects
  • Treatment Outcome

Substances

  • Thalidomide
  • Dacarbazine
  • Temozolomide