What side effects are associated with this type of intervention?

Common treatments for Germ Cell Tumors include chemotherapy, surgery, and radiation therapy. Chemotherapy, particularly with cisplatin-based regimens, can lead to side effects such as nephrotoxicity, neurotoxicity, ototoxicity, and increased risk of cardiovascular disease. Surgery can result in complications like infection, bleeding, and long-term issues such as infertility. Radiation therapy may cause skin irritation, fatigue, and secondary malignancies. For treatments similar to LTLD with MR-HIFU hyperthermia, potential side effects could include localized pain, burns, and tissue damage due to the thermal ablation process, as well as systemic effects from the chemotherapeutic agents used in targeted drug delivery.

What prior FDA approvals exist?

The provided context does not include specific information about FDA approvals for the treatment of Germ Cell Tumors or related drugs. However, it does mention investigational treatments like LTLD with MR-HIFU hyperthermia, which involves targeted drug delivery and thermal ablation. This approach is being studied for its potential in treating refractory or relapsed solid tumors, which may include Germ Cell Tumors. For a comprehensive understanding of FDA-approved treatments for Germ Cell Tumors, consulting additional medical literature or clinical guidelines would be necessary.

What other types of research exist?

Promising novel alternatives for germ cell tumors in 2024 include: 1) Immunotherapy agents such as checkpoint inhibitors (e.g., pembrolizumab, nivolumab) which have shown efficacy in various solid tumors. 2) Targeted therapies like PARP inhibitors (e.g., olaparib) for tumors with specific genetic mutations. 3) Advanced radiotherapy techniques such as stereotactic body radiotherapy (SBRT) for precise targeting of tumors. 4) Combination therapies involving chemotherapy and novel agents to enhance treatment efficacy. Patients should discuss these options with their oncologist to determine the best personalized treatment plan.

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Chemotherapy

Thermodox + MR-HIFU for Cancer

Phase 2

Recruiting

Led By AeRang Kim, MD, PhD

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

RENAL FUNCTION: Serum creatinine ≤ ULN for age/sex OR a creatinine clearance ≥60 mL/min/1.73 m2

PERFORMANCE STATUS: Lansky/Karnofsky performance level ≥ 50%

Must not have

Target lesion in the skull

Inability to tolerate stationary position during HIFU

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to thirty days after last dose of protocol therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a heat-activated drug and a non-invasive heating technology to treat patients with hard-to-treat or recurring tumors. The drug is activated by heat, and then higher heat is used to destroy the tumor cells.

Who is the study for?

This trial is for individuals aged 12 or older with certain types of solid tumors that have not responded to standard treatments. Participants must be in a stable health condition, with specific requirements for blood cell counts and organ function. They should have at least one tumor accessible to HIFU treatment and no other curative options available.

What is being tested?

The study tests the combination of LTLD (a type of chemotherapy) with MR-HIFU, which uses magnetic resonance imaging to guide focused ultrasound for heating and destroying cancer cells. The goal is to see if this approach is effective in treating relapsed or refractory solid tumors.

What are the potential side effects?

Potential side effects include those commonly associated with doxorubicin such as nausea, vomiting, hair loss, mouth sores, and heart damage. The HIFU procedure may cause discomfort or pain at the target site, skin burns, or damage to nearby tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal or near normal.

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I can do most activities but need help with some.

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My cancer returned or didn't respond to initial treatment, and no other curative treatments are available.

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My heart pumps well, with an ejection fraction over 50%.

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My blood tests show enough neutrophils and platelets without recent transfusions.

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My liver tests are within the required range.

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My cancer is confirmed through tissue examination.

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I am 12 years old or older.

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I have a tumor that can be reached with high-intensity focused ultrasound.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a tumor in my skull.

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I cannot stay still for long periods during treatments.

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I am not pregnant or breast-feeding.

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My treatment area is close to major nerves or my spine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 day and 1 week after mr-hifu treatment on first 21-day cycle

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 day and 1 week after mr-hifu treatment on first 21-day cycle

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 day and 1 week after mr-hifu treatment on first 21-day cycle for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary objective 1: Response of treated target lesion(s) assessed by CT or MRI

Primary objective 2: The number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria of Adverse Events (CTCAE) v.5

Other study objectives

Exploratory objective 1: Response of non-target lesion(s) assessed by CT or MRI

Exploratory objective 2: Participant reported target tumor pain intensity assessed using the Numerical Rating Scale-11 (NRS-11)

Exploratory objective 3: Participant reported impact of pain on daily activities assessed using the PROMIS Pain Interference Scale (PROMIS-PI)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All PatientsExperimental Treatment2 Interventions

LTLD 50 mg/m2 will be administered intravenously over 30 minutes on day 1 of every 21-day cycle. MR-HIFU hyperthermia will follow infusion (+/- 30 minutes) for one hour to a target area with a target temperature of 40-45°C followed by ablation therapy (\>55°C). The HIFU hyperthermia regimen will have a duration of at least 60 minutes and will then be followed by ablation therapy. Patients may receive up to a total of 6 cycles. Subsequent treatment cycles may treat alternative target lesions. Disease status will be evaluated using standard imaging techniques (CT/MR) post each cycle.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Germ Cell Tumors (GCTs) include chemotherapy, surgery, and radiation therapy. Chemotherapy, often using cisplatin-based regimens, works by damaging the DNA of cancer cells, leading to cell death. Surgery involves the physical removal of tumors, while radiation therapy uses high-energy rays to kill cancer cells. The pilot study of LTLD with MR-HIFU hyperthermia combines targeted drug delivery and thermal ablation. LTLD (Liposomal ThermoDox) releases chemotherapy drugs directly at the tumor site when heated, enhancing drug concentration and minimizing systemic toxicity. MR-HIFU (Magnetic Resonance-guided High-Intensity Focused Ultrasound) uses focused ultrasound waves to heat and ablate tumor tissues precisely. These mechanisms are crucial for GCT patients as they offer a more targeted approach, potentially improving treatment efficacy and reducing side effects compared to conventional therapies.