Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV
| Status: | Archived |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | June 2010 |
| End Date: | July 2014 |
Phase II Trial of mTOR Inhibitor Temsirolimus (CCI-779) Combined With MEK Inhibitor AZD 6244 in Treatment-naïve Patients With BRAF Mutant Stage IV Melanoma
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.
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.
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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