A Phase 1 interventional study of temsirolimus and temozolomide in Unspecified Childhood Solid Tumor, Protocol Specific, sponsored by National Cancer Institute (NCI). Completed at 25 sites in 2 countries. Open to participants aged 2 Years to 21 Years. Per ClinicalTrials.gov, last updated 2014-04-10.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
This phase I trial studies the side effects and the best dose of temsirolimus when given together with irinotecan hydrochloride and temozolomide in treating younger patients with recurrent or refractory solid tumors. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus with combination chemotherapy may kill more tumor cells.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 72 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy;
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min OR a serum creatinine based on age and/or gender as follows:
Exclusion Criteria:
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.
Drug: temsirolimus · Drug: temozolomide · Drug: irinotecan hydrochloride · Other: laboratory biomarker analysis
Given IV
Also known as: CCI-779, cell cycle inhibitor 779, Torisel
Given orally
Also known as: SCH 52365, Temodal, Temodar, TMZ
Given IV
Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Correlative studies
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
A descriptive summary of all toxicities will be reported.
Time frame: Up to 30 days post-treatment
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
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)