Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV

Part of paid clinical trials in Tampa, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01166126
Phase
PHASE2
Status
Terminated

Conditions

  • Mucosal Melanoma
  • Recurrent Melanoma
  • Stage IV Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • temsirolimus — DRUG
    Given IV
  • selumetinib — DRUG
    Given orally
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

The purpose of this study is to find out how often two investigational drugs that are given together will shrink the patient's tumor and how well they will prolong the time it takes their tumor to grow. The investigators also wish to find out how they affect certain substances in the patient's tumor and in their blood important for tumor growth. The combination of these drugs is experimental, and has not been proven to help treat melanoma

Key Dates

Start date
Oct 31, 2010
Status verified
Dec 2012
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (temsirolimus and selumetinib)
    Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4). As many as 38 patients will receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 will be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 will be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 will be given every 8 weeks. The TEMSIROLIMUS will be injected in a vein over 30 minutes. The continuation phase begins with visits at weeks 12 in patients who receive at least two cycles of treatments.

Primary Outcome Measure

Number of Participants With Complete Response (CR) and Partial Response (PR) [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

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By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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