MK2206 + Hydroxychloroquine for Advanced Cancers

Recruiting in Palo Alto (17 mi)

Jyoti Malhotra, M.D., M.P.H, Thoracic ...

Overseen ByJyoti Malhotra, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206 together with hydroxychloroquine in treating patients with advanced solid tumors, melanoma, prostate or kidney cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Akt inhibitor MK2206 together with hydroxychloroquine may kill more tumor cells than giving either drug alone.

Eligibility Criteria

This trial is for adults with advanced solid tumors, melanoma, prostate or kidney cancer who have tried at least one standard treatment. They must be able to swallow tablets, not be pregnant or breastfeeding, and agree to use contraception. People with certain eye diseases, uncontrolled diabetes, active infections or heart problems can't join.

Inclusion Criteria

I am fully active and can carry on all pre-disease activities without restriction.

I can swallow tablets whole without needing to crush or chew them.

Exclusion Criteria

I can swallow and retain medication without issues.

I am not pregnant or nursing.

I am HIV-positive and not on antiretroviral therapy.

I have a liver condition like cirrhosis or chronic hepatitis.

My heart's electrical cycle is normal and I'm not on QT-prolonging drugs.

I do not have any severe illnesses or social situations that would interfere with the study.

My diabetes is not under control, with high blood sugar or HbA1c levels.

I do not have psoriasis or porphyria.

I do not have a G-6PD deficiency.

I am currently being treated for rheumatoid arthritis or lupus.

I am diabetic and use insulin to control my blood sugar.

I am not currently on any experimental treatments besides this study.

I am not taking hydroxychloroquine for malaria.

I have no eye damage from previous 4-aminoquinoline use.

I do not have serious heart rhythm problems.

Participant Groups

The trial tests the combination of Akt Inhibitor MK2206 and Hydroxychloroquine on tumor growth. MK2206 blocks enzymes needed for cell growth while Hydroxychloroquine aims to kill or stop tumor cells from dividing and spreading.

1Treatment groups

Experimental Treatment

Group I: Treatment (Akt inhibitor MK2206, hydroxychloroquine)Experimental Treatment2 Interventions

Patients receive Akt inhibitor MK2206 PO on days 1, 8, and 15. Beginning on cycle 2, patients also receive hydroxychloroquine PO BID on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.