Study on Gemcitabine, Docetaxel, and Hydroxychloroquine for Treating Recurrent or Resistant Osteosarcoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03598595

Provider View

This clinical trial is testing a combination of three drugs—gemcitabine, docetaxel, and hydroxychloroquine—to see if they can effectively treat osteosarcoma that has returned or is not responding to other treatments. The study aims to find the best dose and understand the side effects of this combination.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of three drugs—gemcitabine, docetaxel, and hydroxychloroquine—can help control osteosarcoma that has come back or is not responding to treatment. These drugs work in different ways to stop cancer cells from growing, dividing, or spreading. The study will also determine the best dose of hydroxychloroquine to use with the other two drugs and will monitor the side effects.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of hydroxychloroquine when used with gemcitabine and docetaxel. In Phase II, they will see if this combination can control the disease better than previous treatments.

Participants will take hydroxychloroquine by mouth once or twice a day for 21 days, receive gemcitabine through an IV on days 1 and 8, and receive docetaxel through an IV on day 8. This cycle repeats every 21 days as long as the disease does not progress and side effects are manageable.

After finishing the treatment, participants will have follow-up visits for up to a year to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of osteosarcoma, either at the initial diagnosis or at recurrence.
  • The cancer must have returned or not responded to standard treatments, which may include high-dose methotrexate, doxorubicin, cisplatin, and/or ifosfamide.
  • Can have either unresectable or potentially resectable disease, but must be willing to wait for surgery until after the primary study endpoint at 4 months.
  • Must have measurable disease according to specific medical criteria.
  • Must have a performance status score of 2 or less, indicating the ability to carry out daily activities with some limitations.
  • Must provide a tumor sample or be willing to undergo a biopsy before treatment and during the second cycle of therapy.
  • Must meet specific blood count and organ function criteria, including adequate neutrophil, platelet, and hemoglobin levels, and normal liver and kidney function.
  • Women of childbearing potential must agree to use effective contraception during the study and for a specified period after the last dose.

Exclusion Criteria

  • Cannot participate if unable to give informed consent or comply with study procedures.
  • Cannot have a history of severe allergic reactions to any of the study drugs.
  • Cannot have previously received gemcitabine or docetaxel.
  • Must agree to use effective birth control methods if of reproductive potential.
  • Cannot be pregnant or breastfeeding.
  • Cannot have another active cancer, except for certain non-threatening types.
  • Cannot have had a heart attack or severe heart problems recently.
  • Cannot have an active infection requiring IV antibiotics.
  • Cannot have significant digestive disorders that affect drug absorption.
  • Cannot have active hepatitis B or C, or HIV.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have participated in another investigational study recently.
  • Cannot have had major surgery recently.
  • Cannot have any medical condition that increases the risk of treatment side effects.
  • Cannot be taking certain supplements without approval from the study doctor.
  • Cannot have pre-existing eye conditions like maculopathy or retinopathy.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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