CLINICAL TRIAL

Magnetic resonance high intensity focused ultrasound for Pediatrics Cancer

1 Prior Treatment
Refractory
Relapsed
Recruiting · < 65 · All Sexes · Washington, United States

This study is evaluating whether a combination of a drug and a focused ultrasound may be effective for treating children with cancer.

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About the trial for Pediatrics Cancer

Eligible Conditions
Pediatrics Cancer · Tumors, Solid · Osteosarcoma · Wilms Tumor · Germ Cell Tumors · Neoplasms · Soft Tissue Sarcoma (STS) · Ewing Sarcoma · Neoplasms, Hepatic · Rhabdomyosarcoma · Neoplasms, Germ Cell and Embryonal · Neuroblastoma · Sarcoma · Sarcoma, Ewing · Liver Neoplasms

Treatment Groups

This trial involves 2 different treatments. Magnetic Resonance High Intensity Focused Ultrasound is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Magnetic resonance high intensity focused ultrasound
DEVICE
+
Lyso-thermosensitive liposomal doxorubicin
DRUG
Experimental Group 2
Magnetic resonance high intensity focused ultrasound
DEVICE
+
Lyso-thermosensitive liposomal doxorubicin
DRUG

Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Pediatrics Cancer or one of the other 14 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must have at least one tumor that is accessible to HIFU, which will be defined as the target lesion show original
Patient's cancer has a recurrence after initial treatment or fails to respond to currently available treatments; no other potential cures are available. show original
People must have gotten better from the bad effects of all the chemotherapy, immunotherapy, or radiation therapy they've had before starting this study. show original
Biologic agents (such as retinoids or tyrosine kinase inhibitors) must be discontinued at least 7 days prior to study entry. show original
Patients must not have received myelosuppressive chemotherapy within 3 weeks of study entry show original
A: People who are ≤21 years of age are not allowed to gamble in this casino show original
This text is about different types of solid tumors, which can include things like rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, and germ cell tumors. show original
The patient can have received any number of previous chemotherapy regimens. show original
If you are planning on participating in a clinical trial that involves immunotherapy, you will need to make sure that your last dose of immunotherapy is at least 4 weeks prior to study entry. show original
Target lesion(s) that can be seen on an x-ray. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 18 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 18 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 18 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Magnetic resonance high intensity focused ultrasound will improve 4 primary outcomes and 3 secondary outcomes in patients with Pediatrics Cancer. Measurement will happen over the course of 3 weeks.

Determine the Changes in Pharmacodynamic Immune Markers in Participants
3 WEEKS
To determine the changes in immune markers in children treated with LTLD and MR-HIFU by examining blood samples from participants
3 WEEKS
Maximum tolerated dose of LTLD
3 WEEKS
To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of LTLD administered in combination with MR-HIFU ablation in children with relapsed/refractory solid tumors by examining blood samples collected from participants
3 WEEKS
Pharmacokinetics of LTLD
8 DAYS
Analyze blood samples of participants to characterize the pharmacokinetic properties of LTLD administered in combination with MR-HIFU
8 DAYS
Antitumor Activity of the Treatment
UP TO 18 WEEKS
To preliminarily determine the antitumor activity of LTLD with MR-HIFU within the confines of a phase 1 study by examining the response of target lesions using RECIST criteria v1.1
UP TO 18 WEEKS
Feasibility of treatment
UP TO 18 WEEKS
To determine the feasibility of LTLD administered at the recommended dose in combination with MR-HIFU induced mild hyperthermia (MHT) as determined by patient outcomes and adverse events
UP TO 18 WEEKS
Social Impact of the Treatment on Participants
UP TO 18 WEEKS
To determine changes in symptoms and quality of life in children treated with LTLD and MR-HIFU by administering the Symptom Distress Scale and Peds QL v4.0 to participants
UP TO 18 WEEKS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for sarcoma?

While there are many different forms of treatment, radiation therapy is often the preferred option for sarcoma treatment. Staging, if needed, is most often done postoperatively. Radiation can relieve pain and stabilize the patient. Chemotherapy can be performed following surgery. Radiation therapy alone is effective in curing almost two-thirds of patients with sarcoma. It generally has a good prognosis; however, in 20 per cent of patients, it can be fatal. Survival is usually limited to months after diagnosis; with early diagnosis, the possibility of long life spans is almost always an option of recovery. Staging for sarcoma depends on many variables, and it is not an absolute method for predicting prognosis.

Anonymous Patient Answer

What are the signs of sarcoma?

There are no absolute signs of sarcoma, such as a palpable mass, enlargement of a lymph node or a lump or discolouration of the skin, and most cases are diagnosed in a routine examination. The only certainty is if the diagnosis of sarcoma is suggested by a change in symptoms. In cases of soft tissue sarcoma, the absence of any obvious signs in the tumour or its surroundings after an initial clinical examination is a sign of a false-positive diagnosis; this is more frequently seen in the case of recurrent disease. In more extreme cases, surgeons performing biopsies on patients may observe the presence of tumour cells in the resected soft tissue that may not be present at the initial operation.

Anonymous Patient Answer

What causes sarcoma?

In this group, there were a number of possible causes of SPMs with no clear single causative factor. Further research into this large population of patients and cancers of unknown cause will be important.

Anonymous Patient Answer

What is sarcoma?

The most common type of cancer in children in North America is the soft-tissue sarcoma, the most common being Ewing's sarcoma. Most sarcomas occur around the trunk or lower limbs. They are usually diagnosed in children between 10 and 15 years Old.\n

Anonymous Patient Answer

How many people get sarcoma a year in the United States?

About 4750 new cases of soft-tissue sarcoma were diagnosed in 2014. It is estimated that 870 of them would be fatal. There is a relatively higher mortality from sarcoma in the US when compared to all other developed nations, including Canada and the United Kingdom.

Anonymous Patient Answer

Can sarcoma be cured?

These are the first reported clinical trial results showing a reduction of sarcoma growth in vaccinated mice when comparing cancer mice vaccinated on post-treatment day 14 versus mice vaccinated on day 21 and 24. Because of our findings, we have successfully tested our hypothesis and are proceeding with our trial in patients with high doses of an intratumoral CTL treatment regimen to evaluate whether these vaccine constructs stimulate T cells and lead to cancer cell death in patients with stage IV or advanced stage metastatic sarcoma. Thus, using autologous tumor-derived dendritic cell vaccines, in combination with intratumoral CTL, we have found a new approach to treat advanced-stage sarcoma patients with an immune vaccine.

Anonymous Patient Answer

What are the latest developments in magnetic resonance high intensity focused ultrasound for therapeutic use?

HIFU is a well established in vivo modality when applied in the clinical world. With the development of an HIFU system that offers very dynamic energy delivery and precise application of a therapeutic ultrasound beam, this modality is set to become more clinically relevant.

Anonymous Patient Answer

How serious can sarcoma be?

In humans the average median survival is 4 years; it’s rare to have a survival as long as 9 years, but there are exceptions as, for example, in those with hemangiosarcoma, which is extremely rare and usually fatal. With such limited information available on the case series I had to extrapolate my result to a range: 2-8 years (with the median value for those with soft tissue sarcomas and 3 years for those with osteosarcomas). This means that this particular sarcoma is usually treated when diagnosed with the aim of prolonging overall survival in the patient.

Anonymous Patient Answer

What is the primary cause of sarcoma?

In Sarcoma, genetic predisposition is the primary cause, with external factors being secondary causes. It is my opinion that if we can, at least to some extent, identify the primary cause of sarcoma, there will be advancements in treatment options for sarcomas.

Anonymous Patient Answer

Does sarcoma run in families?

The risk of developing sarcoma appears to be independent of the family members' age and age at diagnosis, however, there is a clear association for specific lineages as is seen with other hereditary cancer syndromes.

Anonymous Patient Answer
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