A Phase 1 interventional study of irinotecan hydrochloride and temozolomide in Brain and Central Nervous System Tumors and Unspecified Childhood Solid Tumor, Protocol Specific, sponsored by Children's Oncology Group. Completed at 18 sites in 2 countries. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by Children's Oncology Group · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of irinotecan. Patients are stratified according to UGT1A1 genotype (high-risk [7/7 or 6/7 genotype AND bilirubin ≥ 0.6 mg/dL] vs low-risk [absence of high-risk criteria]) if a high-risk patient experiences a dose-limiting toxicity (DLT).
Patients receive oral temozolomide on days 1-5 and oral irinotecan on days 1-5 and 8-12. Patients also receive vincristine IV over 1 minute on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT.
After completion of study treatment, patients are followed for 1 month and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 18 months.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 42 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed* malignant solid tumor, including brain tumor, at original diagnosis or relapse
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine based on age as follows:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 3 months since prior stem cell transplantation or rescue without total-body irradiation
Chemotherapy
Prior temozolomide, vincristine, irinotecan, or topotecan allowed
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent enzyme-inducing anticonvulsants, including any of the following:
No concurrent administration of any of the following:
see detailed description
Drug: irinotecan hydrochloride · Drug: temozolomide · Drug: vincristine sulfate
Determine maximum tolerated dose (MTD) of oral irinotecan
To estimate the maximum tolerated dose (MTD) of oral irinotecan administered on two different schedules together with fixed-dose temozolomide and vincristine in children with refractory solid tumors or brain tumors
Time frame: length of study
To preliminarily define the antitumor activity
To preliminarily define the antitumor activity of this drug combination within the confines of a Phase 1 study.
Time frame: Length of study
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Oncology Group