Status:
WITHDRAWN
Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
M.D. Anderson Cancer Center
Conditions:
Melanoma
Recurrent Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II portion of the trial is studying the side effects and best dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with metastatic, rec...
Detailed Description
PRIMARY OBJECTIVES: * To evaluate the clinical activity, in terms of overall response rate (complete and partial response), of this regimen in these patients. (Phase II) * To evaluate the in vivo bio...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed melanoma, meeting 1 of the following criteria: recurrent or unresectable stage III disease, stage IV disease, non-choroidal origin.
- Tumor must be accessible to biopsy unless appropriate tumor sample collection has occurred within the past 3 months and patient agrees to provide these samples for this study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Bilirubin normal
- Creatinine normal or creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after completion of study treatment.
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib or temsirolimus.
- No uncontrolled hypertension, defined as systolic blood pressure \> 140 mm Hg on 2 separate days \< 1 week prior to study entry OR diastolic pressure \> 90 mm Hg on 2 separate days \< 1 week prior to study entry.
- No evidence of bleeding diathesis or coagulopathy.
- No condition that would impair the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication; requirement for IV alimentation; or active peptic ulcer disease).
- No uncontrolled illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness or social situations that would limit study compliance.
- No traumatic injury within the past 3 weeks.
- No more than 1 prior systemic chemotherapy regimen for metastatic melanoma (Phase II).
- No prior sorafenib, temsirolimus, or any other agents targeting raf, vascular endothelial growth factor (VEGF)/VEGF receptor, or mTOR (Phase II).
- No prior surgical procedures affecting absorption.
- At least 3 weeks since prior major surgery.
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) for melanoma and recovered.
- At least 4 weeks since prior radiotherapy and recovered.
- Prior biologic or immunotherapeutic regimens allowed.
- Prior regional chemotherapy regimens (e.g., isolated limb perfusion) allowed but only 1 prior regional chemotherapy regimen allowed if all target lesions are within the prior regional treatment field.
- No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following: phenytoin, carbamazepine, phenobarbital, rifampin or Hypericum perforatum (St. John's wort).
- No concurrent prophylactic hematopoietic colony-stimulating factors.
- No other concurrent investigational agents.
- No other concurrent anticancer agents or therapies for this cancer.
- No concurrent full-dose anticoagulation (i.e., warfarin, IV heparin, or low-molecular weight heparin).
- No concurrent grapefruit or grapefruit juice.
- No concurrent combination antiretroviral therapy for HIV-positive patients.
- Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin) allowed provided prothrombin time (PT) international normalized ratio (INR) \< 1.1 times upper limits of normal (ULN).
- Unidimensionally measurable disease \>= 20 mm by conventional techniques or \>= 10 mm by spiral computed tomography (CT) scan (longest diameter to be recorded) and margins of visible cutaneous metastatic lesions should be clearly defined and measured in at least one dimension as \>= 10 mm.
- No known brain metastases unless the following criteria are met: no radiographical evidence of recurrences in the brain \>= 3 months after complete resection of the brain metastases, asymptomatic brain metastases stable for \>= 3 months since whole-brain radiation therapy and/or stereotactic radiosurgery and must not require steroid for brain metastases.
- White Blood Count (WBC) \>= 3,000/mm³
- Absolute neutrophil count \>= 1,500/mm³
- Platelet count \>= 100,000/mm³
- Serum cholesterol =\< 350 mg/dL
- Triglycerides =\< 400 mg/dL
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 2.5 times upper limit of normal.
- No peripheral neuropathy \> grade 2.
- At least 5 years since prior chemotherapy for other types of cancer.
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01851408
Start Date
April 1 2006
End Date
February 1 2012
Last Update
April 15 2015
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