Temsirolimus + Metformin for Advanced Cancer

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: CYP3A4 modifiers

Disqualifiers: Pregnancy, Infection, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks for Cycle 1, 4 weeks for subsequent cycles

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of temsirolimus and metformin hydrochloride in treating patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced or metastatic). Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Metformin hydrochloride is a drug used to treat diabetes that may also prevent or slow the growth of cancers. Giving temsirolimus and metformin hydrochloride together may kill more tumor cells.

Research Team

Aung Naing, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with advanced or metastatic cancer that's resistant to standard treatments, relapsed, or has no effective standard therapy. Participants must have stable vital signs and organ function, not be pregnant or breastfeeding, agree to use contraception, and be able to take oral medication. They should be recovered from previous therapies and not on certain drugs affecting liver enzymes.

Inclusion Criteria

Creatinine < 1.5 mg/dl in males and < 1.4 in females

Ability to understand and willingness to sign a written informed consent document

Platelets >= 75,000/mL

Exclusion Criteria

I have severe heart failure.

I haven't had a stroke, heart attack, or severe chest pain in the last 6 months.

I have not had major surgery in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive temsirolimus and metformin. Cycle 1 includes a 2-week metformin titration period followed by 4 weeks of combined treatment. Subsequent cycles are 4 weeks long.

6 weeks for Cycle 1, 4 weeks for subsequent cycles

Weekly visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment. Includes imaging every 8 weeks and more frequently if needed.

4 weeks

Visits every 8 weeks for imaging

End-of-Study Visit

Final assessments including physical exam, performance status, and routine tests within 30 days after last dose.

Treatment Details

Interventions

• Metformin
• Temsirolimus

Trial Overview The study tests the combination of temsirolimus (an enzyme blocker) and metformin hydrochloride (a diabetes drug potentially slowing cancer growth) in patients with advanced cancers. It aims to determine the safest doses while observing how well these drugs work together against tumor cells.

Participant Groups

Group I: Temsirolimus + Metformin Experimental Treatment 2 Interventions

Starting dose of Temsirolimus 25 mg by vein weekly. Metformin titrated over 3 weeks at 500 mg by mouth daily. Four weeks of treatment constitute 1 cycle. Cycle one (1) however, will be 6 weeks long to allow for metformin titration.

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Glucophage for:

• Type 2 diabetes

Approved in United States as Glucophage for:

• Type 2 diabetes

Approved in Canada as Glucophage for:

• Type 2 diabetes

Approved in Japan as Glucophage for:

• Type 2 diabetes

Approved in China as Glucophage for:

• Type 2 diabetes

Approved in Switzerland as Glucophage for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+