Triple Drug Therapy for Osteosarcoma

Recruiting in Palo Alto (17 mi)

Overseen byJohn A Livingston, MD MS

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of hydroxychloroquine and how well it works when given together with gemcitabine and docetaxel in treating participants with osteosarcoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as gemcitabine, docetaxel, and 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.

Eligibility Criteria

This trial is for people with osteosarcoma that has returned or isn't responding to treatment. They must have a certain level of kidney function, measurable disease, and be able to perform daily activities with some limitations. Participants need available tumor tissue for research and should not have had previous treatments with the drugs being tested in this study.

Inclusion Criteria

Absolute neutrophil count (ANC) >= 1.0 x 10^9/L

I can care for myself and am up more than 50% of my waking hours.

My liver enzymes are within normal limits for my age.

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Exclusion Criteria

I haven't had cancer treatment in the last 21 days, or targeted therapy in the last 28 days.

I do not have acute hepatitis B or C, but if chronic, it is stable and not a safety risk.

I have an eye condition affecting my macula or retina.

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Treatment Details

Interventions

Docetaxel (Taxane)
Gemcitabine (Anti-metabolites)
Hydroxychloroquine (Other)

Trial OverviewThe trial is testing the combination of three chemotherapy drugs: gemcitabine, docetaxel, and hydroxychloroquine. It aims to find the safest doses and see how well they work together against recurrent or stubborn osteosarcoma by stopping cancer cells from growing or spreading.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (hydroxychloroquine, gemcitabine, docetaxel)Experimental Treatment3 Interventions

Participants receive hydroxychloroquine PO QD or BID on days 1-21, gemcitabine IV over 90 minutes on days 1 and 8, and docetaxel IV over 1 hours on day 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as Taxotere for: