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 States, Canada42 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 range
1 Year – 21 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine maximum tolerated dose (MTD) of oral irinotecan