Temsirolimus, Irinotecan Hydrochloride, and Temozolomide in Treating Younger Patients With Relapsed or Refractory Solid Tumors
|ClinicalTrials.gov Identifier: NCT01141244|
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : April 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Childhood Solid Tumor, Protocol Specific||Drug: temsirolimus Drug: temozolomide Drug: irinotecan hydrochloride Other: laboratory biomarker analysis||Phase 1|
I. To estimate the maximum tolerated dose (MTD) or recommended Phase 2 dose and schedule of temsirolimus administered in combination with irinotecan (irinotecan hydrochloride) and temozolomide every three weeks to children with recurrent or refractory solid tumors.
II. To define and describe the toxicities of the combination of temsirolimus, irinotecan and temozolomide administered on this schedule.
I. To preliminarily define the antitumor activity of the combination of temsirolimus, irinotecan, and temozolomide within the confines of a Phase 1 study.
II. To collect preliminary data regarding the biologic effects of temsirolimus on proteins involved in signaling pathways of interest in pediatric solid tumors.
OUTLINE: This is a multicenter study, dose-escalation study of temsirolimus.
Patients receive temsirolimus intravenously (IV) over 30 minutes on days 1 and 8 or on days 1, 8, and 15 and temozolomide orally (PO) and irinotecan hydrochloride PO on days 1-5. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up for 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Temsirolimus in Combination With Irinotecan and Temozolomide in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||November 2013|
Experimental: Treatment (temsirolimus, irinotecan, temozolomide)
Patients receive temsirolimus IV over 30 minutes on days 1 and 8 or on days 1, 8, and 15 and temozolomide PO and irinotecan hydrochloride PO on days 1-5. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: temozolomide
Other Names:Drug: irinotecan hydrochloride
Other Names:Other: laboratory biomarker analysis
- MTD of temsirolimus defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT) as graded by the National Cancer Institute (NCI) CTCAE version 4.0 [ Time Frame: Up to 21 days ]
- Incidence of adverse events as graded by NCI CTCAE version 4.0 [ Time Frame: Up to 30 days post-treatment ]A descriptive summary of all toxicities will be reported.
- Disease response (complete or partial response, stable disease, or progressive disease) assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 30 days post-treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141244
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|Principal Investigator:||Rochelle Bagatell||COG Phase I Consortium|