A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors (NCT04791228) | Clinical Trial Compass
WithdrawnPhase 2
A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors
Stopped: Low enrollment.
United States0Started 2022-11-10
Plain-language summary
This is a pilot study of LTLD with MR-HIFU hyperthermia followed by ablation in subjects with refractory/relapsed solid tumors.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* AGE: ≥ 12 years of age.
* DIAGNOSIS: Histologically confirmed malignant solid tumors
* TUMOR LOCATION: Patient must have at least one tumor located in areas accessible to HIFU, which will be defined as the target lesion(s). Target lesions must be reachable within the normal safety margins of HIFU as specified in the instructions for use.
* TARGET LESION(S): Radiographically measurable/evaluable solid tumor target lesion(s).
* THERAPEUTIC OPTIONS:
\- Malignant Tumor: The patient's cancer must have relapsed after or failed to respond to frontline curative therapy and there must not be other potentially curative treatment options available.
* PRIOR THERAPY:
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering on this study.
* No limitation on the number of prior chemotherapy regimens that the patient may have received prior to study entry.
* Myelosuppressive chemotherapy: The last dose of all myelosuppressive anticancer drugs must be at least 3 weeks prior to study entry (6 weeks for prior nitrosoureas) Prior treatment with anthracyclines is allowed as long as total cumulative dose is ≤ 450 mg/m2.
* Immunotherapy: The last dose of immunotherapy (monoclonal antibody or vaccine) must be at least 3 weeks prior to study entry.
* Biologic (anti-cancer agent): The last dose of all biologic agents for the treatment of the patient's cancer (such as retinoids or t…
What they're measuring
1
Primary objective 1: Response of treated target lesion(s) assessed by CT or MRI
Timeframe: At the end of every 21-day cycle
2
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
Timeframe: Up to thirty days after last dose of protocol therapy