Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors (NCT00020150) | Clinical Trial Compass
CompletedPhase 1
Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors
United StatesStarted 2000-06
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating children who have solid tumors that have not responded to previous therapy.
Who can participate
Age range21 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:
* Histologically confirmed solid tumor refractory to standard therapy and for which no potentially curative therapy exists, including, but not limited to:
* Rhabdomyosarcoma and other soft tissue sarcomas
* Ewing's family of tumors
* Osteosarcoma
* Neuroblastoma
* Wilms' tumor
* Hepatic tumors
* Germ cell tumors
* Primary brain tumor
* Histological confirmation may be waived for brainstem or optic gliomas
* Measurable or evaluable disease
* Evidence of progressive disease on prior chemotherapy or radiotherapy or persistent disease after prior surgery
PATIENT CHARACTERISTICS:
Age:
* 21 and under
Performance status:
* ECOG 0-2
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute granulocyte count greater than 1,500/mm\^3
* Hemoglobin greater than 8 g/dL
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin normal
* SGPT less than 2 times upper limit of normal
* No significant hepatic dysfunction
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No significant cardiac dysfunction
Pulmonary:
* No significant pulmonary dysfunction
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to swallow capsules
* No significant unrelated systemic illness that would preclude study (e.g., serious infections or organ dysfunction)
* No prior hypersensitivity to dacarbazine, temozolomide, or polyethylene glycol…