ABT-751 in Treating Young Patients With Refractory Solid Tumors (NCT00036959) | Clinical Trial Compass
CompletedPhase 1
ABT-751 in Treating Young Patients With Refractory Solid Tumors
United States90 participantsStarted 2002-03
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects of ABT-751 in treating young patients with refractory solid tumors.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor\*, including, but 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
* Brain stem or optic gliomas (histological confirmation may be waived if a biopsy has not been performed) NOTE: \*Closed to accrual for all diagnoses except neuroblastoma as of 4/16/05
* Relapsed after or failed to respond to frontline standard therapy and no other standard treatment options (e.g., surgery, radiotherapy, chemotherapy, or any combination of these modalities) exist
* Measurable or evaluable disease\* NOTE: \*Not required for patients with neuroblastoma
* No CNS tumor with motor or sensory deficits that would obscure the study assessment of sensory neuropathy
PATIENT CHARACTERISTICS:
Age:
* 18 and under
Performance status:
* Lansky 60-100% (age 10 and under)
* Karnofsky 60-100% (age 11 to 18)
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT and AST no greater than 2.5 times ULN (5 times ULN for patients treated after the maximum tolerated dose is determined)
* No clinically significant hepatic dysfunction
Renal:
* Creatinine normal for age OR
* Creatinine clearance …
Trial details
NCT IDNCT00036959
SponsorNational Institutes of Health Clinical Center (CC)