RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma.
OBJECTIVES: Primary * To establish the maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus in patients with advanced solid cancers or lymphoma. Secondary * To determine the toxicity and safety, with particular reference to glucose and lipid deregulation, of this regimen in these patients. * To assess antitumor activity, including tumor response rate and time to progression, in patients treated with this regimen. OUTLINE: This is a dose-escalation study of metformin hydrochloride. Patients receive oral metformin once, twice, or three times daily on days 1-28 and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus
Toxicity and safety, with particular reference to glucose and lipid deregulation
Antitumor activity, including tumor response rate and time to progression
Objective response
Survival
Frequency and severity of adverse events
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