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Recurrent Pulmonary OsteosarcomaPhase 1/2RNA PRIMENCT05660408

RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors

A Phase 1/2 study testing pp65 RNA LP (DP1), pp65/tumor mRNA RNA-LP (DP2) and Surgical Biopsy/Resection in people with Recurrent Pulmonary Osteosarcoma and Recurrent High-grade Glioma, run by University of Florida at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The Investigators have demonstrated in preclinical studies that RNA liposomes activate APCs, induce antigen-specific T cell immunity, and can supplant DCs in a cell therapy model for HGG and have shown feasibility and activity of this approach in preclinical models and in canine patients with a spontaneous malignant… Read more about this study

Who is it for?
Ages 3 to 39 years
What is being tested?
pp65 RNA LP (DP1), pp65/tumor mRNA RNA-LP (DP2) and Surgical Biopsy/Resection
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
12 Mar 2025to Oct 2035
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 39 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with recurrent or progressive pediatric high-grade glioma (pHGG)
  • Patients must be age 3-25 years
  • Diagnosis:
  • Patients must have had a prior histologically-diagnosed pHGG(including but not limited to: Astrocytoma WHO Grade 3 or 4 and Glioblastoma WHO Grade 4 by histopathology or molecular studies, per 2021 WHO Classification of Tumors of the CNS57, WHO CNS5).
  • Patients with M+ disease without gliomatosis cerebri (see definition under exclusion criteria) ARE eligible.
  • Recurrent pHGG involving the midline structures other than those intrinsically located within the pons ARE eligible.
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  • Patients with mismatch repair deficient (MMRD) tumors refractory to immune checkpoint inhibitors ARE eligible.
  • Patients must have recurred or progressed after receiving surgery/biopsy and radiation therapy as frontline standard-of-care treatments in primary disease.
  • Patients must have MRI evidence of probable recurrent pHGG. Patients must be clinically eligible for standard-of-care surgical resection/biopsy and sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles.
  • Performance Level Karnofsky ≥ 60% for patients ≥ 16 years of age and Lansky ≥ 60% for patients ≤ 16 years of age
  • Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  • Participants with post-surgical neurological deficits should have deficits that are stable for a minimum of 2 week prior to enrollment.
  • Prior Therapy
  • Patients must have recovered from all acute toxic effects of all prior anti-cancer therapy (all adverse events must have improved to grade 1 or better):
  • Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: ≥ 21 days after the last dose of myelosuppressive chemotherapy. If questions, the agent and duration can be discussed with the study chair.
  • Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts): ≥ 14 days after the last dose of agent. If questions, the agent and duration can be discussed with the study chair.
  • Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.
  • Corticosteroids: All systemically administered corticosteroids must be stable or decreasing for ≥ 1 week prior to enrollment, with a maximum dexamethasone dose of 2.8 mg/m2/day. Corticosteroid physiologic replacement therapy for management of pituitary/adrenal axis insufficiency and/or topical administration (e.g. inhaled or dermatologic) is allowed.
  • Hematopoietic growth factors: ≥14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.
  • Interleukins, Interferons, and Cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon, or cytokines.
  • Stem cell infusions (with or without TBI):
  • Autologous stem cell infusion including boost infusion: ≥ 30 days.
  • Cellular Therapy: ≥ 42 days after the completion of any type of cellular therapy (e.g., modified T cells, NK cells, dendritic cells, etc.)
  • XRT/External Beam Irradiation, including Protons: ≥ 90 days after local XRT unless recurrence is a new enhancement on MRI outside the radiation treatment field; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis.
  • Radiopharmaceutical therapy (e.g., radiolabeled antibody): ≥ 42 days after systematically administered radiopharmaceutical therapy.
  • Other therapeutic clinical trials: ≥ 14 days after last dose of investigational agent, unless otherwise defined above.
  • Prior use of RNA-LP therapy: Patients must not have received prior exposure to pp65-directed therapy or any RNA-LP therapy.
  • Organ Function Requirements
  • Adequate bone marrow function as defined as:
  • Absolute neutrophil count (ANC) ≥ 1,000/µl
  • Platelets ≥ 100,000/µl (transfusion-independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • Hemoglobin ≥ 8 g/dL (transfusion-independent, defined as not receiving packed red blood cell transfusions for at least 7 days prior to enrollment)
  • Adequate renal function as defined as:
  • A creatinine based on age/gender
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2
  • Adequate liver function as defined as:
  • Total bilirubin ≤ 3x institutional upper limits of normal for age
  • ALT ≤ 5x institutional upper limits of normal for age
  • AST ≤ 5x institutional upper limits of normal for age Adequate pulmonary function defined as baseline pulse oximetry of at least 92% on room air.
  • All patients must be willing to take an antiepileptic medication such as levetiracetam for the duration of RNA-LP vaccinations.
  • Contraception
  • Women of childbearing potential must agree to use of at least 2 forms of acceptable contraceptive methods or abstinence to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.
  • Men with female partners of childbearing potential must agree to use of at least 2 forms of acceptable contraceptive methods or abstinence throughout the study and should avoid conceiving children for at least 24 weeks following the last dose of study drug.
  • All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent/assent document.
  • Patients with osteosarcoma (OSA)
  • Age: Patients must be age 3-39 years. Diagnosis
  • For Arms 1 and 2: Patients must be clinically eligible for standard-of-care surgical resection of suspected OSA recurrence with pulmonary-only metastases.
  • For Arm 3: Patients must undergo standard-of-care biopsy of suspected or known recurrent, unresectable OSA.
  • Disease Status
  • For Arm 1: Patients must be eligible for single-sided thoracotomy for planned surgical resection of all OSA pulmonary metastases.
  • For Arm 2: Patients must be eligible for staged two-sided thoracotomies for planned surgical resection of all OSA pulmonary metastases.
  • For Arm 3: Patients must have unresectable OSA. Patients must have sufficient disease on diagnostic contrast-enhanced MRI wherein surgical biopsy is feasible.
  • Patients must have sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles.
  • Performance Level: Karnofsky ≥ 60% for patients > 16 years of age and Lansky ≥ 60% for patients < 16 years of age.
  • NOTE: Participants who are unable to walk because of amputation, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  • Prior Therapy: Patients must have recovered from all acute toxic effects of all prior anti-cancer therapy (all adverse events must have improved to grade 1 or better):
  • Prior Therapy: Patients must have recovered from all acute toxic effects of all prior anti-cancer therapy (all adverse events must have improved to grade 1 or better):
  • Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: ≥ 14 days after the last dose of myelosuppressive chemotherapy. If questions, the agent and duration can be discussed with the study chair.
  • Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts): ≥ 7 days after the last dose of agent. If questions, the agent and duration can be discussed with the study chair.
  • Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.
  • Corticosteroids: All systemically administered corticosteroids must be stable or decreasing for ≥ 1 week prior to enrollment, with a maximum dexamethasone dose of 2.8 mg/m2/day. Corticosteroid physiologic replacement therapy for management of pituitary/adrenal axis insufficiency and/or topical administration (e.g. inhaled or dermatologic) is allowed.
  • Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥ 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.
  • Interleukins, Interferons, and Cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon, or cytokines.
  • Stem cell infusions (with or without TBI): Autologous stem cell infusion including boost infusion: ≥ 30 days.
  • Cellular Therapy: ≥ 42 days after the completion of any type of cellular therapy (e.g., modified T cells, NK cells, dendritic cells, etc.).
  • XRT/External Beam Irradiation, including Protons: ≥ 90 days after local XRT unless recurrence is a new enhancement on MRI outside the radiation treatment field; ≥ 150 days after TBI or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial BM radiation.
  • Radiopharmaceutical therapy (e.g., radiolabeled antibody): ≥ 42 days after systematically administered radiopharmaceutical therapy.
  • Other therapeutic clinical trials: ≥ 14 days after last dose of investigational agent, unless otherwise defined above
  • Prior use of RNA-LP therapy: Patients must not have received prior exposure to pp65-directed therapy or any RNA-LP therapy.
  • Organ Function Requirements
  • Adequate bone marrow function as defined as:
  • Absolute neutrophil count (ANC) ≥ 1,000/µl
  • Platelets ≥ 100,000/µl (transfusion-independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • Hemoglobin ≥ 8 g/dL (transfusion-independent, defined as not receiving packed red blood cell transfusions for at least 7 days prior to enrollment)
  • Adequate renal function as defined as:
  • A creatinine based on age/gender
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2
  • Adequate liver function as defined as:
  • Total bilirubin ≤ 3x institutional upper limits of normal for age
  • ALT ≤ 5x institutional upper limits of normal for age
  • AST ≤ 5x institutional upper limits of normal for age Adequate pulmonary function defined as baseline pulse oximetry of at least 92% on room air.
  • Contraception
  • Women of childbearing potential must agree to use of at least 2 forms of acceptable contraceptive methods or abstinence to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.
  • Men with female partners of childbearing potential must agree to use of at least 2 forms of acceptable contraceptive methods or abstinence throughout the study and should avoid conceiving children for at least 24 weeks following the last dose of study drug.
  • All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent/assent document.

Who cannot join

  • Diagnosis
  • Diffuse intrinsic pontine glioma
  • Gliomatosis cerebri - clear tumor involvement of multiple areas (>3 lobes), OR presence of clinical and/or radiographic evidence of impending herniation or spinal cord compression.
  • NOTE: review by Study Chairs is recommended
  • Patients who are receiving any other investigational agents.
  • Pregnancy or Breastfeeding
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  • o Pregnant or breastfeeding women will not be entered on this study because there is no available information regarding human fetal or teratogenic toxicities. Females of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to starting protocol therapy.
  • Severe, active co-morbidity, including, but not limited to:
  • Known active immunosuppressive disease.
  • Unstable angina and/or congestive heart failure requiring hospitalization.
  • Unstable cardiac arrhythmias, abnormalities, or transmural myocardial infarction within the last 6 months.
  • Uncontrolled infection
  • Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other known respiratory illness requiring hospitalization or precluding study therapy
  • Hepatic insufficiency resulting in clinical jaundice and/or clinically significant coagulation defects.
  • Patients with autoimmune disease requiring medical management with immunosuppressants.
  • Prior history of brachial neuritis or Guillain-Barre syndrome.
  • Uncontrolled seizure disorder
  • Major medical illnesses or psychiatric impairments that, in the investigators' opinions, will prevent administration or completion of protocol therapy.
  • History of myocarditis
  • Receipt of any live vaccine within 30 days prior to day 1 of treatment.
  • Patients who have received an allogeneic (non-autologous) bone marrow or stem cell transplant, or any allogeneic stem cell infusion including DLI or boost infusion.
  • Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations, or who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UF Health

    Gainesville, Florida, 32608

Other trials in United States

About this study

Official title: RNA PRIME - RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors

The Investigators have demonstrated in preclinical studies that RNA liposomes activate APCs, induce antigen-specific T cell immunity, and can supplant DCs in a cell therapy model for HGG and have shown feasibility and activity of this approach in preclinical models and in canine patients with a spontaneous malignant glioma. In one arm of this study, we will investigate the safety and immunologic activity of RNA-LP vaccines in pediatric patients with recurrent pHGG.

The investigators have also shown that intravenous administration of tumor mRNA loaded lipid particles (LPs) localizes primarily to lung, transfect antigen presenting cells (APCs) and lead to an activated T cell response for induction of anti-tumor immunity. In contrast to other formulations, RNA-LPs recruit multiple arms of the immune system (i.e. innate/adaptive), and remodel the systemic/intratumoral immune milieu, which remain potent barriers for vaccine, cellular, and checkpoint inhibiting immunotherapies. After only a single RNA-LP vaccine, the bulk of systemic and intratumoral dendritic cells (DCs) in mice display an activated phenotype; these activated DCs (harvested from tumors) expand antigen specific T cell immunity. In immunologically resistant pulmonary osteosacroma murine tumor models (i.e. K7M2), RNA-LPs induce robust anti-tumor efficacy in settings where immune checkpoint inhibitors (i.e. anti-PD-L1 therapy) do not confer therapeutic benefit. The investigators have already demonstrated safety of RNA-LPs in acute/chronic murine toxicity studies, and in client-owned canine trial.

In this study, we will investigate the manufacturing feasibility, safety and immunologic activity of RNA-LP vaccine in patients with recurrent pulmonary or unresectable osteosarcoma and recurrent pHGG.

Read the detailed description

For recurrent pHGG there will be two non-randomized arms assigned at the discretion of the patient and treatment team:

  • Arm 1-A single neoadjuvant pp65 RNA-LP (DP1) will be administered prior to surgical resection/biopsy, and then two adjuvant DP1.
  • Arm 2-Surgical resection/biopsy will occur first and all three DP1 will be administered in the adjuvant setting

For recurrent OSA there will be three arms based on disease status on enrollment:

  • Arm 1-Patients with unilateral pulmonary-only metastatic recurrent OSA
  • Arm 2-Patients with bilateral pulmonary-only metastatic recurrent OSA
  • Arm 3-Patients with unresectable OSA in any location.

The Phase I dose-escalation study for either recurrent/progressive pHGG or recurrent OSA cohort will be performed in 18 subjects using a 3+3 design. Both recurrent pHGG trial arms will be enrolled together as a single cohort for safety, and similarly all recurrent OSA trial arms will be enrolled together as a single cohort for safety during phase I.

Being tested
pp65 RNA LP (DP1), pp65/tumor mRNA RNA-LP (DP2), Surgical Biopsy/Resection
Keywords
pulmonary osteosarcoma, RNA-LP, vaccines, immunotherapy, high-grade glioma, brain tumor
Medical subject headings
Glioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pp65 RNA LP (DP1)Biological

    This is an off the shelf RNA-LP vaccine used to prime for the immune response while we produce the patient specific pp65/tumor mRNA RNA-LP (DP2)

  • pp65/tumor mRNA RNA-LP (DP2)Biological

    This is a patient specific RNA-LP vaccine generated from the patient's tumor RNA.

  • Surgical Biopsy/ResectionProcedure or surgery

    Eligible participants will be enrolled and undergo sterile collection of tumor material .

Study groups in NCT05660408
Study groupRoleWhat they receive
Recurrent pHGG, Arm 1ExperimentalpHGG Arm 1-A single dose of pp65 RNA-LP (DP1) will be administered prior to standard of care surgical resection/biopsy, followed by at least two adjuvant DP1. During production of pp65/tumor mRNA RNA-LP (DP2) vaccines, treatment with DP1 will continue every 2 weeks. DP1 vaccines may continue until production of DP2 is complete (expected 5-8 weeks following initial surgery/biopsy). pp65/tumor mRNA RNA-LP (DP2) vaccinations will begin 7-14 days after the last dose of pp65 RNA-LP (DP1). DP2 treatment will occur approximately every 2 weeks for the first 3 doses. Following the first 3 doses of DP2, patients will receive 9 cycles of monthly DP2 for a total of 12 DP2 vaccines (minimum of 15 overall vaccines).
Receives: Biological: pp65 RNA LP (DP1); Biological: pp65/tumor mRNA RNA-LP (DP2); Procedure: Surgical Biopsy/Resection
Recurrent pHGG, Arm 2ExperimentalpHGG Arm 2-Standard of care surgical resection/biopsy will occur first and all three pp65 RNA-LP (DP1) will be administered in the adjuvant setting. During production of DP2, treatment will begin with DP1 every 2 weeks, beginning a minimum of 7-14 days after surgery/biopsy. DP1 vaccines may continue until production of DP2 is complete (expected 5-8 weeks following initial surgery/biopsy). pp65/tumor mRNA RNA-LP (DP2) vaccinations will begin 7-14 days after the last dose of pp65 RNA-LP (DP1). DP2 treatment will occur approximately every 2 weeks for the first 3 doses. Following the first 3 doses of DP2, patients will receive 9 cycles of monthly DP2 for a total of 12 DP2 vaccines (minimum of 15 overall vaccines).
Receives: Biological: pp65 RNA LP (DP1); Biological: pp65/tumor mRNA RNA-LP (DP2); Procedure: Surgical Biopsy/Resection
Arm 1-Patients with unilateral pulmonary-only metastatic recurrent OSAExperimentalOSA Arm 1-Patients with unilateral pulmonary-only metastatic recurrent OSA Participants will undergo surgical resection for sterile collection of tumor material to make pp65/tumor mRNA RNA-LP (DP2). During production of DP2 vaccines, participants will begin treatment with off-the-shelf pp65 RNA-LP (DP1) vaccines every 2 weeks. A minimum of 3 DP1 vaccines will be administered and may continue until production of DP2 is complete (expected 5-8 weeks following initial surgery/biopsy). DP2 vaccinations will begin 7-14 days after the last dose of DP1. DP2 treatment will occur approximately every 2 weeks for the first 3 doses. Participants will receive 9 cycles of monthly DP2 for a total of 12 DP2 vaccines (minimum of 15 overall vaccines).
Receives: Biological: pp65 RNA LP (DP1); Biological: pp65/tumor mRNA RNA-LP (DP2); Procedure: Surgical Biopsy/Resection
Arm 2-Patients with bilateral pulmonary-only metastatic recurrent OSAExperimentalOSA Arm 2-Patients with bilateral pulmonary-only metastatic recurrent OSA Participants will undergo surgical resection for sterile collection of tumor material to make pp65/tumor mRNA RNA-LP (DP2). For subjects in Arm 2, surgery will be again performed on contralateral lung nodules within 7 days following DP1 Vaccine #3. During production of pp65/tumor mRNA RNA-LP (DP2) vaccines, participants will begin treatment with off-the-shelf pp65 RNA-LP (DP1) vaccines every 2 weeks. A minimum of 3 DP1 vaccines will be administered and may continue until production of DP2 is complete (expected 5-8 weeks following initial surgery/biopsy). DP2 vaccinations will begin 14 days after 2nd surgical pulmonary metastectomy. DP2 treatment will occur approximately every 2 weeks for the first 3 doses. Participants will receive 9 cycles of monthly DP2 for a total of 12 DP2 vaccines (minimum of 15 overall vaccines).
Receives: Biological: pp65 RNA LP (DP1); Biological: pp65/tumor mRNA RNA-LP (DP2); Procedure: Surgical Biopsy/Resection
Arm 3-Patients with unresectable OSA in any locationExperimentalArm 3-Patients with unresectable OSA in any location. Participants will undergo surgical biopsy for sterile collection of tumor material to make pp65/tumor mRNA RNA-LP (DP2). For adult subjects only in Arm 3, optional biopsy will be repeated within 7 days following DP2 Vaccine #3 administration once hematologic recovery to eligibility criteria, unless medically contraindicated. During production of DP) vaccines, participants will begin treatment with off-the-shelf pp65 RNA-LP (DP1) vaccines every 2 weeks, beginning a minimum of 7 days after initial surgery/biopsy. A minimum of 3 DP1 vaccines will be administered and may continue until production of DP2 is complete (expected 5-8 weeks following initial surgery/biopsy). DP2 vaccinations will begin 7-14 days after the last dose of DP1. DP2 treatment will occur approximately every 2 weeks for the first 3 doses. Participants will receive 9 cycles of monthly DP2 for a total of 12 DP2 vaccines (minimum of 15 overall vaccines).
Receives: Biological: pp65 RNA LP (DP1); Biological: pp65/tumor mRNA RNA-LP (DP2); Procedure: Surgical Biopsy/Resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

    Determine the maximum tolerated dose of RNA-LP vaccine based on frequency of dose-limiting toxicities.

    Measured: 14 months

  2. Feasibility of generating RNA-LP

    Ability to generate patient-specific pp65/tumor mRNA RNA-LP that meet release criteria.

    Measured: 14 months

Secondary outcomes (2)

  1. Overall survival rate

    Determine the survival in patients with recurrent pHGG or oseteosarcoma receiving RNA-LP vaccine.

    Measured: 3 years

  2. Immune activation

    Determine if immune cells in patients receiving RNA-LPs become activated in both peripheral blood and in the tumor.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start12 Mar 2025
  3. Primary completionOct 2033 (estimated)
  4. Study completionOct 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05660408
Sponsor's protocol ID
MCC23450
Other IDs
OCR43060, MCC23450
Acronym
RNA PRIME
Status last verified
Oct 2026
First submitted
13 Dec 2022
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing pp65 RNA LP (DP1), pp65/tumor mRNA RNA-LP (DP2) and Surgical Biopsy/Resection in people with Recurrent Pulmonary Osteosarcoma and Recurrent High-grade Glioma, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 85 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05660408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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