Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors (NCT00138216) | Clinical Trial Compass
CompletedPhase 1
Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors
United States42 participantsStarted 2005-10
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, vincristine, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and vincristine in treating young patients with refractory solid tumors.
Who can participate
Age range1 Year – 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:
* Histologically confirmed\* malignant solid tumor, including brain tumor, at original diagnosis or relapse
* Refractory disease NOTE: \*Histologic confirmation not required for intrinsic brain stem tumors
* Measurable or evaluable disease
* No known curative therapy OR therapy proven to prolong survival with an acceptable quality of life exists
* No known bone marrow metastases
PATIENT CHARACTERISTICS:
Age
* 1 to 21
Performance status
* Lansky 50-100% (for patients ≤ 10 years of age)
* Karnofsky 50-100% (for patients \> 10 years of age)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)
Hepatic
* ALT ≤ 110 U/L (upper limit of normal \[ULN\] for ALT is 45 U/L)
* Bilirubin ≤ 1.5 times ULN
* Albumin ≥ 2 g/dL
Renal
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
* Creatinine based on age as follows:
* No greater than 0.8 mg/dL (for patients ≤ 5 years of age)
* No greater than 1.0 mg/dL (for patients 6 to 10 years of age)
* No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
* No greater than 1.5 mg/dL (for patients \> 15 years of age)
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Neurologic deficits in patients with CNS tumors must be stable for ≥ 1 week prior to study entry…
What they're measuring
1
Determine maximum tolerated dose (MTD) of oral irinotecan