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

Summary

This is a phase I study of temsirolimus (Torisel) combined with dexamethasone, cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).

Conditions

• Lymphoblastic Leukemia, Acute, Childhood
• Lymphoblastic Lymphoma
• Peripheral 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

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• Therapeutic Advances in Childhood Leukemia Consortium

  lead OTHER

Principal Investigators

• Susan Rheingold, MD · Children's Hospital of Philadelphia

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

1 Year

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-03

Primary Completion

2019-12-15

Completion

2020-09-04

FDA Drug

Yes

Countries

• United States
• Australia
• Canada

Study Locations