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| Name | Class |
|---|---|
| Aprea Therapeutics | INDUSTRY |
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This research study is testing whether a new study drug (called ATRN-119) is safe and effective when combined with a single, highly targeted dose of radiation therapy (called stereotactic body radiation therapy or SBRT) to treat early-stage throat cancer that is caused by HPV.
The goal of this study is to treat cancer effectively while reducing side effects and helping patients maintain a better quality of life over the long term. Researchers hope that this approach will be just as successful-or possibly more successful-than current treatments, which already have high cure rates.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Patients will take 800mg of ATRN-119 every day for 10 days. On day 3 of dosing, they will return to clinic for 1 fraction of SBRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATRN-119 | Drug | ATRN-119 at 800 mg QD (every day) for 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Feasibility of a neo-adjuvant approach combining ATRN with SBRT before TORS | This will be judged by whether patients are able to have their planned surgery within 6 weeks after the study treatment, and whether there are no problems during surgery that the study doctor believes were caused by the study treatment. | Within 6 weeks after study treatment |
| Phase II: Major pathologic response (MPR) rate of radiated nodal disease | Researchers will measure how many patients have a strong treatment response in the affected lymph nodes that were treated with radiation, based on what is seen when the tissue is examined. | Immediately after standard of care primary tumor removal surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: To assess safety of ATR inhibitor ATRN-119 with nodal SBRT prior to surgery | This will be judged based on whether there are any surgery problems that the study doctor thinks were caused by the earlier treatment, as well as any side effects from the treatment. | From start of study treatment through standard of care 2-year Follow-Up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Relapse-free survival (RFS) at two years | Participants will be checked over a 2-year period to see if their disease comes back. A "relapse" means the disease returns either in the same place, nearby areas, or elsewhere in the body. Any return of the disease must be confirmed with medical testing (like examining tissue under a microscope). | From the completion of treatment, either surgery in those not receiving adjuvant therapy, or completion of all adjuvant therapy and will last for 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nick Lukens, MD | Contact | 215-662-6567 | RadOncCRU@PennMedicine.upenn.edu | |
| Casey Hanna | Contact | 215 - 615 - 1611 | casey.hanna@pennmedicine.upenn.edu |
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| Stereotactic Body Radiation Therapy (SBRT) |
| Radiation |
10 Gy administered to nodal disease (neck) only on day 3 of ATRN-119 dosing |
|
| Phase II: Radiographic response rates | This looks at how many patients' tumors shrink or improve based on imaging tests like scans. This is assessed by comparing pre- and post- study treatment MRI (or CT) Neck scans using typical descriptive changes noted by a head and neck specialized radiologist. | Pre-treatment MRI will be taken prior to enrollment as part of standard of care. Post-treatment Research MRI will be completed 1 week before standard of care tumor removal surgery. |
| Phase II: Type of adjuvant treatment required | Percentage of patients requiring additional radiation therapy +/- chemotherapy after their main treatment as compared to historic controls (e.g. 75% requiring RT, 25% requiring chemotherapy). Additional therapy is determined by the participant's care team as part of their standard of care treatment, so not all patients will receive additional radiation or chemotherapy. | Within 4 months of primary tumor removal surgery |
| Phase II: Pathologic response of primary tumor and nodal disease | This looks at how strongly the main tumor and the affected lymph nodes respond to treatment. Pathologic response rates will be determined by comparing pre- and post- surgery tumor tissue samples for patients who have enough pre-op tissue to analyze from pathology. | Immediately after primary tumor removal surgery |
| Phase II: Assessment of Patient Reported quality of life | Patients will be asked to take the M.D. Anderson Head & Neck Symptom Inventory Questionnaire (MDASI-HN) at multiple timepoints throughout the study. The MDASI Head and Neck (MDASI-HN) questionnaire is scored by averaging patient-rated items on a 0-10 scale covering 13 core symptoms, 9 head/neck-specific symptoms, and 6 interference items. Higher scores indicate greater symptom severity and worse interference with daily life. | From enrollment to 24 Month Follow-Up Visit |
| Phase II: Measures of activation of anti-tumor immunity in primary tumor and blood | Researchers will study samples taken from each patient's main tumor and blood both before and after treatment given prior to the main therapy. This helps them see how the treatment affects the cancer and the body. | From enrollment to date of primary tumor removal surgery |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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