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

Conditions

• Iris Melanoma
• Medium/Large Size Posterior Uveal Melanoma
• Ocular Melanoma With Extraocular Extension
• Recurrent Uveal Melanoma
• Small Size Posterior Uveal Melanoma
• Stage IV Uveal Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dacarbazine — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Selumetinib — DRUG
  Given PO
• Temozolomide — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Jun 30, 2010

Status verified

Jun 2017

Primary completion

May 31, 2016

Completion

May 31, 2016

Study Design

Enrollment

120 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (temozolomide)
  Patients receive temozolomide PO 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 IV every 3 weeks (with approval from the Principal Investigator). Patients who experience disease progression may crossover to arm II.
• Experimental: Arm II (selumetinib)
  Patients receive selumetinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) (Evaluable Randomized Patients) [ Time Frame: The time from randomization to the earlier date of objective disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression, assessed up to 5 years ]

Locations (32)

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