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Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL

NCT01523977 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-07-18

No results posted yet for this study

Summary

Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus is approved for use in the United States for certain types of cancer, such as kidney cancer. It has been extensively studied in people with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of other drugs. Studies in adults with cancer have also evaluated Everolimus in combination with other anti-tumor drugs. Information from lab studies and some other clinical trials suggests that Everolimus may kill leukemia cells on its own, and also make it more likely that steroids (such as prednisone) are able to kill leukemia cells.

In this research study, we are looking to learn more about how Everolimus works in combination with other drugs which are commonly used to treat relapsed acute lymphoblastic leukemia (prednisone, vincristine, PEG-asparaginase, and doxorubicin). The main goal of the study is to evaluate the side effects of this treatment combination in order to determine a safe dose of Everolimus which can be given with these other 4 drugs.

Conditions

Interventions

DRUG

Everolimus

Orally, daily days 1-32 per assigned dose level

DRUG

Prednisone

40 mg/m2/day orally 3 x daily days 4-32

DRUG

Vincristine

1.5 mg/m2 IV daily on days 4, 11, 18, and 25

DRUG

PEG-Asparaginase

2,500 U/m2 IV 1 x daily on days 5 and 18

DRUG

Doxorubicin

30 mg/m2 IV on days 4 and 5

DRUG

Dexrazoxane

300 mg/m2 IV on days 4 and 5

Sponsors & Collaborators

Principal Investigators

  • Lewis Silverman, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2017-01-31
Completion
2018-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01523977 on ClinicalTrials.gov