Centro de Cáncer de Cabeza y Cuello

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck

   Rochester, Minn.

   This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or transmit tumor killing molecules to them. It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.

2. Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.

3. A Study to Evaluate Endoscopic Endonasal Skull Base Surgery and Pituitary Surgery Quality of Life

   Rochester, Minn.

   The objectives of this study are to:

   • • Measure the short and long-term overall and nasal-specific quality of life (QOL) impact of patients undergoing Endoscopic Endonasal Skull Base Surgery (EESBS) for pituitary and sellar lesions.
     • Determine the relative difference in QOL impact of EESBS for patients undergoing surgery for functional and nonfunctional pituitary adenomas.
     • Generate baseline data to development and validate a site-specific endoscopic-specific comprehensive QOL for EESBS.
     • Particular tumors of interest include pituitary tumors, Rathke’s cleft cysts, craniopharyngiomas, clival chordomas and chondrosarcomas.
     • Specific QOL aims focus on olfaction (sense of smell), gustation (sense of taste) and nasal function.

    

    

4. Effect of Agent Orange Exposure on Endocrine Tumor Aggressiveness

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The intent is to collect relevant clinical data on patients exposed to Agent Orange plus assessment of the tissue for genetic mutations known to be associated with growth of thyroid cancer and pituitary tumors and report our findings as a descriptive case series.

5. A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.

6. A Study of the Impact of the Terminology Used to Identify Papillary Thyroid Cancer on the Treatment Options Chosen by Patients

   Rochester, Minn.

   The purpose of this study is to explore how using different terms (with or without the word cancer) to identify papillary thyroid cancer might affect the decisions patients would make about treatment.

7. An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of SAR444881 in Patients with Advanced Solid Tumors

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in combination with pembrolizumab, carboplatin, and pemetrexed), A2 (SAR444881 in combination with pembrolizumab), B1 (SAR444881 in combination with pembrolizumab and later therapy), and C1 (SAR444881 in combination with cetuximab and later therapy), as well as Sub-Part 2B (Dose Expansion) with Cohort D1 (monotherapy SAR444881).

8. A Study to Identify Biomarkers in the Blood, Saliva or Tissue for Oropharyngeal Squamous Cell Cancer

   Rochester, Minn.

   The purpose of this study is to identify a biomarker (or biomarkers) that is present when disease is present (i.e., at diagnosis or recurrence) and not present when disease is absent (i.e., after treatment, in HPV negative patients or in normal controls).

9. A Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer

   Rochester, Minn.

   Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.

10. BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study

    Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to evaluate the feasibility of molecular characterization based on tumor mutational burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study. Also, to evaluate the feasibility of molecular characterization based on TMB and gene expression profiling (GEP) (for TIS - tumor inflammation signature) for stratification in the overall study (Stage I and Stage II). Additinoally, to evaluate the effectiveness by overall response rate (ORR – defined as confirmed and unconfirmed partial responses plus complete responses) of cabozantinib plus nivolumab in each disease cohort, both across and within tumor biomarker subgroups.

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck

   Rochester, Minn.

   This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or transmit tumor killing molecules to them. It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.

2. Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.

3. A Study to Evaluate Endoscopic Endonasal Skull Base Surgery and Pituitary Surgery Quality of Life

   Rochester, Minn.

   The objectives of this study are to:

   • • Measure the short and long-term overall and nasal-specific quality of life (QOL) impact of patients undergoing Endoscopic Endonasal Skull Base Surgery (EESBS) for pituitary and sellar lesions.
     • Determine the relative difference in QOL impact of EESBS for patients undergoing surgery for functional and nonfunctional pituitary adenomas.
     • Generate baseline data to development and validate a site-specific endoscopic-specific comprehensive QOL for EESBS.
     • Particular tumors of interest include pituitary tumors, Rathke’s cleft cysts, craniopharyngiomas, clival chordomas and chondrosarcomas.
     • Specific QOL aims focus on olfaction (sense of smell), gustation (sense of taste) and nasal function.

    

    

4. Effect of Agent Orange Exposure on Endocrine Tumor Aggressiveness

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The intent is to collect relevant clinical data on patients exposed to Agent Orange plus assessment of the tissue for genetic mutations known to be associated with growth of thyroid cancer and pituitary tumors and report our findings as a descriptive case series.

5. A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.

6. A Study of the Impact of the Terminology Used to Identify Papillary Thyroid Cancer on the Treatment Options Chosen by Patients

   Rochester, Minn.

   The purpose of this study is to explore how using different terms (with or without the word cancer) to identify papillary thyroid cancer might affect the decisions patients would make about treatment.

7. An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of SAR444881 in Patients with Advanced Solid Tumors

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in combination with pembrolizumab, carboplatin, and pemetrexed), A2 (SAR444881 in combination with pembrolizumab), B1 (SAR444881 in combination with pembrolizumab and later therapy), and C1 (SAR444881 in combination with cetuximab and later therapy), as well as Sub-Part 2B (Dose Expansion) with Cohort D1 (monotherapy SAR444881).

8. A Study to Identify Biomarkers in the Blood, Saliva or Tissue for Oropharyngeal Squamous Cell Cancer

   Rochester, Minn.

   The purpose of this study is to identify a biomarker (or biomarkers) that is present when disease is present (i.e., at diagnosis or recurrence) and not present when disease is absent (i.e., after treatment, in HPV negative patients or in normal controls).

9. A Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer

   Rochester, Minn.

   Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.

10. BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study

    Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to evaluate the feasibility of molecular characterization based on tumor mutational burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study. Also, to evaluate the feasibility of molecular characterization based on TMB and gene expression profiling (GEP) (for TIS - tumor inflammation signature) for stratification in the overall study (Stage I and Stage II). Additinoally, to evaluate the effectiveness by overall response rate (ORR – defined as confirmed and unconfirmed partial responses plus complete responses) of cabozantinib plus nivolumab in each disease cohort, both across and within tumor biomarker subgroups.