Gemcitabine, Docetaxel, and Hydroxychloroquine in Treating Participants With Recurrent or Refract… (NCT03598595) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Gemcitabine, Docetaxel, and Hydroxychloroquine in Treating Participants With Recurrent or Refractory Osteosarcoma
United States31 participantsStarted 2019-01-28
Plain-language summary
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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient or patient's legally acceptable representative has provided informed consent
* Patients must have a pathological diagnosis of osteosarcoma at original diagnosis or time of recurrence
* Patients must have relapsed or become refractory to conventional therapy, with a regimen containing some combination of high dose methotrexate, doxorubicin, cisplatin, and/or ifosfamide
* Patients may have either unresectable or potentially resectable disease. However, patients with potentially resectable disease must be willing to await surgery until after the primary efficacy endpoint is reached at 4 months
* Patients must have measurable disease by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2. Use Karnofsky for patients \> 16 years old and Lansky for patients =\< 16
* Has archived tumor tissue and is willing to provide a tumor block or unstained slides or the patient is willing to undergo a pretreatment biopsy. Biopsy during cycle #2 of therapy is required. Biopsy at progression is strongly encouraged but will be optional
* Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L
* Platelet count \>= 100 x 10\^9/L
* Hemoglobin \> 8 g/dL
* Prothrombin time (PT) or partial thromboplastin time (PTT) \< 1.5 x upper limit of normal (ULN), except subjects on anticoagulation for venous thromboembolism
* Calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 60 mL/min
* Aspartate aminotransferase (AST) and ala…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose of hydroxychloroquine (Phase I)