Nab-paclitaxel in Combination with Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors (NCT03507491) | Clinical Trial Compass
CompletedPhase 1
Nab-paclitaxel in Combination with Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors
United States24 participantsStarted 2018-08-27
Plain-language summary
This is a research study for people who have a solid tumor that was not effectively treated by conventional therapy or for which there is no known effective therapy. This is a phase I study of a drug called nab-paclitaxel used together with gemcitabine. Gemcitabine and nab-paclitaxel will be given intravenously, once a week for 3 out of 4 weeks, for a 28-day cycle.
The goals of this study are:
* To find the highest dose of nab-paclitaxel that can be safely given in combination with gemcitabine without causing severe side effects
* To learn what kind of side effects nab-paclitaxel given in combination with gemcitabine can cause
* To learn more about the pharmacology (how the body handles the drug) of nab-paclitaxel given in combination with gemcitabine
* To evaluate tumor tissue for levels of certain proteins that may help with predicting who will benefit most from treatment with nab-paclitaxel
* To determine whether nab-paclitaxel given in combination with gemcitabine is a beneficial treatment for relapsed and/or refractory solid tumors
Who can participate
Age range
6 Months – 30 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:
* Subjects must be ≥ than 6 months and ≤ 30 years of age at the time of study enrollment.
* Subjects must have had histologic verification of a malignancy at original diagnosis or relapse.
* All subjects with relapsed or refractory solid tumors are eligible, excluding primary CNS tumors.
* Patients with solid tumors and a history of intraparenchymal CNS disease are eligible if their CNS disease was treated surgically or with radiotherapy and stable with no recurrent lesions for at least 3 months from the start of protocol therapy.
* Newly diagnosed patients with ≤15% chance of cure if given standard-of-care chemotherapy are eligible. (Prognosis to be determined at the discretion of the treating physician.)
* Subjects must have either measurable or evaluable disease.
* Karnofsky ≥ 60 for subjects \> 16 years of age and Lansky ≥ 50 for subjects ≤ 16 years of age. Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
* Subjects must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy.
* At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).
* At least 14 days after the last dose of a long-acting growth factor (e.g. Pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administrat…
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.