Study on Sirolimus with Metronomic Chemotherapy for Children with Recurrent or Hard-to-Treat Solid and Brain Tumors

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02574728

Provider View

This clinical trial is testing a combination of medications, including sirolimus and low-dose chemotherapy, to see if they can help shrink tumors in children whose cancer has returned or is not responding to standard treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of daily sirolimus and celecoxib, along with low-dose chemotherapy drugs etoposide and cyclophosphamide, can effectively shrink tumors in children whose cancer has come back or is not responding to treatment. The study will also look at how long this treatment can keep the tumor from growing, the side effects of sirolimus, and how well the treatment is working by examining blood and tumor samples.

Description

This study is exploring whether a combination of medications can help treat children with tumors that have returned or are not responding to standard treatments. The treatment includes taking sirolimus and celecoxib daily, along with alternating cycles of low-dose chemotherapy drugs etoposide and cyclophosphamide every 21 days. Researchers want to see if this combination can shrink tumors, how long it can keep the cancer from growing, and what side effects might occur. They will also study blood and tumor samples to understand how the treatment is working.

Eligibility Criteria

Inclusion Criteria

  • Children with certain types of tumors that have returned after initial treatment or are not responding to standard treatments.
  • Tumors include brain tumors (except diffuse intrinsic pontine glioma) and extracranial solid tumors.
  • Must have a confirmed diagnosis of cancer, except for certain brain tumors with specific markers.
  • Must provide tissue samples for analysis.
  • Must have tumors that can be measured by scans, or specific evaluable disease for neuroblastoma.
  • Must have no other known curative treatment options.
  • Must have a performance status score of 50% or higher, indicating they can carry out daily activities.
  • Must have recovered from any side effects of previous cancer treatments.
  • Must have adequate bone marrow, kidney, and liver function.
  • Must have normal blood fat and sugar levels.
  • Must have adequate lung function.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Taking corticosteroids without a stable dose for at least 7 days.
  • Taking certain medications for seizures or other conditions that affect the liver enzyme CYP3A4.
  • Participating in another clinical trial or taking other cancer treatments.
  • Using cannabis oil during the first two cycles of the study.
  • Have an uncontrolled infection.
  • Unable to comply with study requirements according to the investigator.

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