A phase II study of extended dose temozolomide and thalidomide in previously treated patients with metastatic melanoma.
OBJECTIVE
To assess the efficacy and tolerability of extended dose temozolomide and continuous thalidomide in patients with advanced metastatic cutaneous melanoma.


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.
Laber
Damian A
DA
J. G. Brown Cancer Center, University of Louisville, 529 South Jackson Street, KY 40202, USA. damianla@ulh.org
Okeke
Roseline I
RI
Arce-Lara
Carlos
C
Taft
Beverly S
BS
Schonard
Cassandra L
CL
McMasters
Kelly M
KM
Kloecker
Goetz H
GH
Miller
Donald M
DM
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D008875:Middle Aged; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D000077204:Temozolomide; D013792:Thalidomide / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D013792:Thalidomide; D003606:Dacarbazine; D000077204:Temozolomide