A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 3, 2015

Primary Completion Date

December 15, 2019

Study Completion Date

September 4, 2020

Conditions
Lymphoblastic Leukemia, Acute, ChildhoodLymphoblastic LymphomaPeripheral T-cell Lymphoma
Interventions
DRUG

Temsirolimus

Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.

DRUG

Etoposide

100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.

DRUG

Cyclophosphamide

440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

DRUG

Methotrexate

"PATIENTS WITH CNS 1 COURSES 2, 4, 6, 8: Give intrathecally to patients who were CNS1 at study entry day 1 of each course at the doses listed below.~* Age 1 - 1.99 give 8 mg of methotrexate~* Age 2 - 2.99 give10 mg of methotrexate~* Age 3 - 8.99 give 12 mg of methotrexate~* Age ≥ 9 give 15 mg of methotrexate~PATIENTS WITH CNS 2 or 3 DISEASE~-COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.~COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age"

DRUG

Hydrocortisone

"Given with Methotrexate and Cytarabine for patients with CNS 2 or 3 disease.~COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.~COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age"

DRUG

Cytarabine

"For Patients who are CNS1 COURSE 1: Give intrathecally to patients with CNS1 disease at the dose defined by age below on day 1 of course 1 if no other IT was given within 1 week of day 1 of course 1~* Age 1 - 1.99 give 30 mg of Cytarabine~* Age 2 - 2.99 give 50mg of Cytarabine~* Age ≥ 3 give 70 mg of Cytabine~For Patients with CNS 2 or 3 Disease COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 1 if no other IT chemotherapy given within 1 week of day 1 of course 1. Then give weekly until the patient is CNS 1 or 2 (investigator discretion). No more than 5 weekly doses to be given in cycle 1.~COURSES 2-8: Give intrathecally to patients who were CNS 2or 3 at study entry on day 1 of each course.~* 16 mg for patients age 1-1.99~* 20 mg for patients age 2-2.99~* 24 mg for patients 3-8.99 years of age~* 30 mg for patients \>9 years of age"

Trial Locations (32)

10032

Children's Hospital New York-Presbyterian, New York

19104

Children's Hospital of Philadelphia, Philadelphia

21231

Johns Hopkins University, Baltimore

28203

Levine Children's Hospital at Carolinas Medical Center, Charlotte

30322

Children's Healthcare of Atlanta, Emory University, Atlanta

33136

University of Miami Cancer Center, Miami

44106

Rainbow Babies, Cleveland

75235

University of Texas at Southwestern, Dallas

76104

Cook Children's Medical Center, Fort Worth

77030

Texas Children's Hospital, Houston

80045

The Children's Hospital, University of Colorado, Aurora

90027

Childrens Hospital Los Angeles, Los Angeles

98105

Seattle Children's Hospital, Seattle

Unknown

Children's Hospital Orange County, Orange

Children's National Medical Center, Washington D.C.

Lurie Children's Hospital, Chicago

Nationwide Childrens Hospital, Columbus

Oregon Health and Science University, Portland

Primary Children's, Salt Lake City

Medical College of Wisconsin, Milwaukee

Children's Hospital at Westmead, Westmead

Royal Children's Hospital, Brisbane

Royal Children's Hospital, Melbourne, Melbourne

Sydney Children's Hospital, Sydney

Hospital for Sick Kids, Toronto

Sainte Justine University Hospital, Montreal

British Columbia Children's Hospital, Vancouver

94143-0106

UCSF School of Medicine, San Francisco

02215

Dana Farber, Boston

48109-0914

C.S. Mott Children's Hospital, Ann Arbor

55404-4597

Childrens Hospital & Clinics of Minnesota, Minneapolis

38105-3678

St. Jude, Memphis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Therapeutic Advances in Childhood Leukemia Consortium

OTHER