Studies
| Study First Submitted Date | 2022-12-13 |
| Study First Posted Date | 2022-12-21 |
| Last Update Posted Date | 2023-01-27 |
| Start Month Year | October 2023 |
| Primary Completion Month Year | October 2026 |
| Verification Month Year | January 2023 |
| Verification Date | 2023-01-31 |
| Last Update Posted Date | 2023-01-27 |
Conditions
| Sequence: | 52502201 |
| Name | Pulmonary Osteosarcoma |
| Downcase Name | pulmonary osteosarcoma |
Id Information
| Sequence: | 40395391 |
| Id Source | secondary_id |
| Id Value | OCR43060 |
| Id Type | Other Identifier |
| Id Type Description | University of Florida |
Design Groups
| Sequence: | 55958431 |
| Group Type | Experimental |
| Title | RNA-LP vaccine |
Interventions
| Sequence: | 52810313 |
| Intervention Type | Biological |
| Name | RNA-LP vaccine |
| Description | All subjects will receive two doses of RNA-LP vaccine every two weeks and then once monthly for 12 months afterward. Subjects on the phase 1 portion of the study will be assigned to receive either 0.01 mg/kg mRNA encapsulated in 0.15 mg/kg LPs (dose level -1), 0.02 mg/kg mRNA encapsulated in 0.3 mg/kg LPs (dose level 0), 0.04 mg mRNA encapsulated in 0.6 mg/kg LPs (dose level +1), 0.08 mg mRNA encapsulated in 1.2 mg/kg LPs (dose level +2) following a 3 + 3 design. All subjects on the Phase II portion will receive the maximum tolerated dose determined in the phase I portion of the study. |
Keywords
| Sequence: | 80317831 | Sequence: | 80317832 | Sequence: | 80317833 | Sequence: | 80317834 |
| Name | pulmonary osteosarcoma | Name | RNA-LP | Name | vaccines | Name | immunotherapy |
| Downcase Name | pulmonary osteosarcoma | Downcase Name | rna-lp | Downcase Name | vaccines | Downcase Name | immunotherapy |
Design Outcomes
| Sequence: | 178614959 | Sequence: | 178614960 | Sequence: | 178614961 | Sequence: | 178614962 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Maximum tolerated dose | Measure | 12 month event-free survival | Measure | Event-free survival | Measure | Overall survival |
| Time Frame | 14 months | Time Frame | 12 months | Time Frame | 3 years | Time Frame | 3 years |
| Description | Determine the maximum tolerated dose of RNA-LP vaccine. | Description | Determine if RN-LP vaccine therapy extends 12 month event-free survival. Event-free survival is defined as the time from start of treatment to either disease progression or death, whichever occurs first. | Description | Determine the event-free survival in patients with recurrent pulmonary oseteosarcoma receiving RNA-LP vaccine. Event-free survival is defined as the time from start of treatment to either disease progression or death, whichever occurs first. | Description | Determine the overall survival in patients with recurrent pulmonary oseteosarcoma receiving RNA-LP vaccine. |
Browse Conditions
| Sequence: | 194749681 | Sequence: | 194749682 | Sequence: | 194749683 | Sequence: | 194749684 | Sequence: | 194749685 | Sequence: | 194749686 | Sequence: | 194749687 |
| Mesh Term | Osteosarcoma | Mesh Term | Neoplasms, Bone Tissue | Mesh Term | Neoplasms, Connective Tissue | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Sarcoma |
| Downcase Mesh Term | osteosarcoma | Downcase Mesh Term | neoplasms, bone tissue | Downcase Mesh Term | neoplasms, connective tissue | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | sarcoma |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48625948 | Sequence: | 48625949 |
| Agency Class | OTHER | Agency Class | OTHER |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
| Name | University of Florida | Name | The V Foundation for Cancer Research |
Overall Officials
| Sequence: | 29458088 |
| Role | Principal Investigator |
| Name | John Ligon, MD |
| Affiliation | University of Florida |
Central Contacts
| Sequence: | 12094266 |
| Contact Type | primary |
| Name | Shannon Alford, MPH |
| Phone | (352) 273-8146 |
| PMO@cancer.ufl.edu | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68600064 |
| Design Group Id | 55958431 |
| Intervention Id | 52810313 |
Eligibilities
| Sequence: | 30954203 |
| Gender | All |
| Minimum Age | 0 Years |
| Maximum Age | 39 Years |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Age < 39 years. Histopathologically proven recurrent pulmonary osteosarcoma. Must be eligible for thoracotomy (Arms 1 and 2 only). Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs). Patients must have recovered from the effects of surgery, biopsy, postoperative infection, and other complications. Karnofsky Performance Status (KPS) or Lansky Performance Status (LPS) ≥ 60. Bone Marrow: ANC (Absolute neutrophil count) ≥ 1,000µl (absent treatment) Platelets ≥ 100,000/µl (absent treatment for at least 3 days) Hemoglobin > 8 g/dL Renal: BUN ≤ 25 mg/dl Creatinine ≤ 1.7 mg/dl Hepatic Bilirubin ≤ 2.0 mg/dl ALT ≤ 5 times institutional upper limits of normal for age AST ≤ 5 times institutional upper limits of normal for age Signed informed consent. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the legally authorized representative per institutional policy. For subjects of childbearing potential (SOCBP), negative urine or serum pregnancy test at enrollment. SOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug. Subjects with partners of childbearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug. Exclusion Criteria: HIV, Hepatitis B, CMV, or Hepatitis C seropositive. Known active infection or immunosuppressive disease. Known severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization. Unstable cardiac arrhythmias, abnormalities, or transmural myocardial infarction within the last 6 months. Acute bacterial or fungal infection requiring intravenous antibiotics Chronic Obstructive Pulmonary Disease exacerbation or other known respiratory illness requiring hospitalization or precluding study therapy Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Patients with autoimmune disease requiring medical management with immunosuppressants. Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy. Known active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity. Pregnancy or subjects of childbearing potential and their partners who are sexually active and who are unwilling or unable to use an acceptable method of contraception for the entire study period; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Subjects must not be pregnant or breast-feeding. Subjects who require systemic corticosteroids above physiologic doses or not weaned to physiologic dosing within 1 week of scheduled vaccination. Subjects who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry. Subjects who are unwilling or unable to receive treatment and undergo follow-up evaluations at the enrolled Sunshine Consortium treatment site. |
| Adult | True |
| Child | True |
| Older Adult | False |
Calculated Values
| Sequence: | 253883387 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 0 |
| Maximum Age Num | 39 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
| Number Of Secondary Outcomes To Measure | 2 |
Designs
| Sequence: | 30699783 |
| Allocation | N/A |
| Intervention Model | Sequential Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 29066550 |
| Responsible Party Type | Sponsor |