Temsirolimus, Irinotecan Hydrochloride, and Temozolomide in Treating Younger Patients With Relapsed or Refractory Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01141244
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • temsirolimus — DRUG
    Given IV
  • temozolomide — DRUG
    Given orally
  • irinotecan hydrochloride — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Jun 30, 2010
Status verified
Dec 2013
Primary completion
Nov 30, 2013

Study Design

Enrollment
72 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 ]

Locations (23)

FacilityCityStateZIPSite coordinators
Children's Hospital of AlabamaBirminghamAlabama35233-
University of Alabama at BirminghamBirminghamAlabama35294-
Childrens Hospital of Orange CountyOrangeCalifornia92868-3874-
University of California San Francisco Medical Center-ParnassusSan FranciscoCalifornia94143-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Lurie Children's Hospital-ChicagoChicagoIllinois60614-
Indiana University Medical CenterIndianapolisIndiana46202-
Riley Hospital for ChildrenIndianapolisIndiana46202-
Mark O Hatfield-Warren Grant Magnuson Clinical CenterBethesdaMaryland20892-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
C S Mott Children's HospitalAnn ArborMichigan48109-
University of Minnesota Medical Center-FairviewMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-
Columbia University Medical CenterNew YorkNew York10032-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Oregon Health and Science UniversityPortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
St. Jude Children's Research HospitalMemphisTennessee38105-
University of Texas Southwestern Medical CenterDallasTexas75390-
Baylor College of MedicineHoustonTexas77030-
Seattle Children's HospitalSeattleWashington98105-
Midwest Children's Cancer CenterMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
Children's Hospital of Alabama· Birmingham, ALUniversity of Alabama at Birmingham· Birmingham, ALChildrens Hospital of Orange County· Orange, CAUniversity of California San Francisco Medical Center-Parnassus· San Francisco, CAChildren's National Medical Center· Washington D.C., DCLurie Children's Hospital-Chicago· Chicago, IL

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