Pilot Study on Thermodox and MR-HIFU for Treating Relapsed Solid Tumors

Sponsor: Children's National Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04791228

Provider View

This study is exploring a new treatment approach using Thermodox and MR-HIFU to target and treat solid tumors that have returned or not responded to previous treatments.

Patient Parameters

Program Overview

This pilot study is testing a new treatment method for solid tumors that have come back or not responded to other treatments. It uses a special drug called Thermodox, which releases its cancer-fighting medicine when heated, and a technology called MR-HIFU that can heat the tumor without surgery. The goal is to see if this combination can effectively treat tumors with fewer side effects.

Description

Thermodox is a special form of the drug doxorubicin that is activated by heat. When exposed to temperatures between 40-45°C, it releases the drug directly at the tumor site. This treatment is generally well-tolerated and has similar side effects to regular doxorubicin. MR-HIFU is a non-invasive technology that uses focused ultrasound to heat large areas of tissue, making it a promising tool for activating Thermodox. In this study, patients will receive Thermodox, and then MR-HIFU will be used to maintain a mild heat at the tumor site. After this, a higher heat treatment will be applied to destroy the tumor cells where it is safe to do so. This approach aims to enhance the effectiveness of chemotherapy while minimizing additional side effects, improving local tumor control and drug delivery.

Eligibility Criteria

Inclusion Criteria

  • Age 12 years or older.
  • Diagnosed with a malignant solid tumor.
  • Have at least one tumor that can be reached and treated with HIFU.
  • Tumors must be measurable by scans.
  • Cancer must have returned or not responded to initial treatments, with no other curative options available.
  • Must have recovered from any side effects of previous cancer treatments.
  • No limit on the number of previous chemotherapy treatments.
  • Last dose of chemotherapy must be at least 3 weeks ago (6 weeks for certain drugs).
  • Last dose of immunotherapy must be at least 3 weeks ago.
  • Last dose of biological agents must be at least 7 days ago.
  • Last dose of radiation to major bones must be at least 4 weeks ago, and 2 weeks for other areas.
  • At least 42 days since a stem cell transplant.
  • Last dose of growth factors must be at least 1 week ago (2 weeks for long-acting types).
  • No other cancer treatments allowed during the study.
  • Must have a performance status score of 50% or higher.
  • Must have adequate blood cell counts and organ function.
  • Must have adequate heart function with an ejection fraction over 50%.

Exclusion Criteria

  • Serious unrelated illnesses that could affect the ability to undergo treatment.
  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
  • Must use effective birth control during the study and for 30 days after the last dose.
  • Cannot have implants or prostheses in the path of the HIFU beam.
  • Tumor cannot be too close to nerves, the spinal canal, or bowel.
  • Tumor cannot be in the skull.
  • Cannot undergo MRI or have conditions that prevent MRI use.
  • Cannot stay still during HIFU treatment.
  • Allergic to doxorubicin or its formulations.
  • Currently receiving other cancer treatments or investigational drugs.

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