Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or … (NCT00303940) | Clinical Trial Compass
CompletedPhase 1
Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid Tumors
United States26 participantsStarted 2005-12
Plain-language summary
RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving talabostat together with temozolomide or carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of talabostat when given together with temozolomide or carboplatin in treating young patients with relapsed or refractory brain tumors or other solid tumors.
Who can participate
Age range2 Years – 18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumors, including, but not limited to, any of the following:
* Rhabdomyosarcoma and other soft tissue sarcomas
* Ewing's sarcoma family of tumors
* Osteosarcoma
* Neuroblastoma
* Wilms' tumor
* Hepatic tumors
* Germ cell tumors
* Primary brain tumors
* In patients with brainstem or optic gliomas, requirement for histological confirmation can be waived if biopsy was not performed
* Patients with brainstem gliomas that did not respond to therapy but that are without radiographic evidence of disease progression must have clinical evidence of progression
* Patients with brain tumors must be on stable or tapering dose of corticosteroids for 7 days prior to study entry
* Measurable or evaluable disease
* Relapsed or failed to respond to frontline curative therapy, including any of the following:
* Surgery
* Radiotherapy
* Chemotherapy
* Combination of modalities
* No other potentially curative treatment options available
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 8 mg/dL
* Platelet count ≥ 100,000/mm\^3 (platelet transfusion independent)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGPT ≤ 2.5 times ULN
* Creatinine clearance ≥ 60 mL/min OR age-adjusted creatinine\* as follows:
* No more than 0.8 mg/dL (for patients ≤ 5 years of age)
* No more than 1.0 mg/dL (for patients 6 to 10 years of age)
* No…
Trial details
NCT IDNCT00303940
SponsorNational Institutes of Health Clinical Center (CC)