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 range2 Years – 21 Years
SexALL
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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…
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)