Clinical Trials Directory

Trials / Completed

CompletedNCT01143402

Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye

Randomized Phase II Trial of Temozolomide Versus Hyd-Sulfate AZD6244 [NSC 748727] in Patients With Metastatic Uveal Melanoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
120 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This randomized phase II trial studies temozolomide to see how well it works compared to selumetinib in treating patients with melanoma of the eye that has spread to other places in the body. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective than selumetinib in treating melanoma of the eye.

Detailed description

PRIMARY OBJECTIVES: I. To assess the progression-free survival (PFS) in three separate patient populations with uveal melanoma: Patients on COHORT 1 (guanine nucleotide binding protein \[G protein\], q polypeptide \[Gnaq\]/G protein, alpha 11 \[Gna11\] mutant uveal melanoma; temozolomide \[TMZ\]/dacarbazine \[DTIC\] naive) treated with AZD6244 (selumetinib) or TMZ (or DTIC); patients on both COHORT 1 and COHORT 2 (Gnaq/Gna11 mutant and Gnaq/Gna11 wild-type uveal melanoma; TMZ/DTIC naive) treated with AZD6244 or TMZ (or DTIC); and patients on COHORT 3 (Gnaq/Gna11 mutant or wild-type uveal melanoma; previously treated with TMZ/DTIC) treated with AZD6244. SECONDARY OBJECTIVES: I. Overall survival (OS). II. Overall response rate (RR). III. To determine the tolerability of AZD6244 in patients with advanced uveal melanoma. IV. To correlate PFS, OS, and overall RR with Gnaq and Gna11 mutational status. TERTIARY OBJECTIVES: I. To correlate clinical outcome with baseline phosphorylated (p)-extracellular signal-regulated kinases (ERK), p-v-akt murine thymoma viral oncogene homolog 1 (AKT), and phosphatase and tensin homolog (PTEN) expression by immunohistochemistry. II. To correlate clinical outcome with changes in p-ERK, p-AKT, and PTEN expression by immunohistochemistry. III. To correlate clinical outcome with changes in Ki67 and cleaved caspase 3. IV. To explore the overall quality of life (QoL) of the treatment groups as measured by the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire. V. To explore the radiographic effects of treatment with AZD6244 as assessed by 18F fluorothymidine (FLT)-positron emission tomography (PET) imaging. OUTLINE: Patients in groups 1 and 2 are randomized to 1 of 2 treatment arms. Patients in group 3 are assigned to arm II. ARM I: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are unable to be treated with temozolomide may be treated with dacarbazine intravenously (IV) every 3 weeks (with approval from the Principal Investigator). Patients who experience disease progression may crossover to arm II. ARM II: Patients receive selumetinib PO twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Conditions

Interventions

TypeNameDescription
DRUGDacarbazineGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
OTHERQuality-of-Life AssessmentAncillary studies
DRUGSelumetinibGiven PO
DRUGTemozolomideGiven PO

Timeline

Start date
2010-06-01
Primary completion
2016-05-01
Completion
2016-05-01
First posted
2010-06-14
Last updated
2017-07-26
Results posted
2017-05-18

Locations

33 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT01143402. Inclusion in this directory is not an endorsement.