Ixabepilone in Treating Young Patients With Solid Tumors or Leukemia That Haven't Responded to Th… (NCT00030108) | Clinical Trial Compass
CompletedPhase 1
Ixabepilone in Treating Young Patients With Solid Tumors or Leukemia That Haven't Responded to Therapy
United States30 participantsStarted 2001-11
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating young patients with relapsed or refractory solid tumors or leukemia.
Who can participate
Age range
2 Years – 21 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.
DISEASE CHARACTERISTICS:
* Meets 1 of the following criteria:
* Histologically confirmed solid tumor (closed to accrual as of 10/4/2007) that relapsed after or failed to respond to front-line curative therapy and for which no other potentially curative treatment options exist
* Curative therapy may include surgery, radiotherapy, chemotherapy, or any combination of these modalities
* Eligible tumor types include, but are not limited to, the following:
* Rhabdomyosarcoma
* Other soft tissue sarcomas
* Ewing's sarcoma family of tumors
* Osteosarcoma
* Neuroblastoma
* Wilms' tumor
* Hepatic tumors
* Germ cell tumors
* Primary brain tumors
* Histologic confirmation may be waived for brain stem or optic glioma
* Diagnosis of relapsed or refractory leukemia
* Patients with refractory or second or greater relapsed leukemia must have \> 25% blasts in the bone marrow (M3 bone marrow) with or without active extramedullary disease (except for leptomeningeal disease)
* Relapsed after or failed to respond to frontline curative therapy and no other potentially curative therapy (e.g., radiotherapy, chemotherapy, or any combination of these modalities) exists
* Patients with acute promyelocytic leukemia must be refractory to treatment with retinoic acid and arsenic trioxide
* Patients with Philadelphia chromosome positive chronic myelogenous leukemia must be refractory to imatinib
* No active CNS leuke…
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 and dose-limiting toxicity of ixabepilone
2
Toxicity spectrum
3
Plasma pharmacokinetics
4
Pharmacodynamics
5
Nerve growth factor levels before and after drug administration
Trial details
NCT IDNCT00030108
SponsorNational Institutes of Health Clinical Center (CC)