Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Jonsson Comprehensive Cancer Center
With
OBJECTIVES: Primary * Assess the maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide in patients with stage IIIC or IV malignant melanoma. (Phase I) * Assess the overall safety of this regimen in these patients. (Phase I) * Determine the response rate in patients treated with this regimen. (Phase II) Phase II was never conducted due to toxicity in phase I. Secondary * Determine the response rate in patients treated with this regimen. (Phase I) * Determine the safety and tolerability of this regimen in these patients. (Phase II) * Determine the progression-free survival of patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a phase II study. Patients receive oral sunitinib malate once daily and oral temozolomide once daily on days 1-42. Treatment repeats every 56 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up very 6 months for up to 5 years. Phase II was never conducted due to toxicity in phase I.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
