Squamous Cell Carcinoma Clinical Trial
Official title:
Phase I Trial With Expansion Cohort of OBP-301 (Telomelysin™) and Definitive Chemoradiation for Patients With Locally Advanced Esophageal and Gastroesophageal Cancer Who Are Not Candidates for Surgery
This phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. OBP-301 is a virus that has been designed to infect and destroy tumor cells (although there is a small risk that it can also infect normal cells). Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving OBP-301 with chemotherapy and radiation therapy may work better than standard chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal cancer.
PRIMARY OBJECTIVE: I. To determine if the addition of OBP-301 to chemoradiation with carboplatin/paclitaxel is safe. SECONDARY OBJECTIVES: I. To assess toxicities associated with the addition of OBP-301 to chemoradiation. II. To assess the number of clinical complete responses (cCR). III. To assess the number of patients alive/without progression (progression-free survival [PFS]) and the number of patients alive (overall survival [OS]) at 1 and 2 years. EXPLORATORY OBJECTIVE: I. To report correlate outcomes - cCR, PFS and OS - with immune and virus-based correlative assays. OUTLINE: This study will evaluate an initial dose of OBP-301 and a de-escalated dose, if needed. Patients receive OBP-301 by intratumoral injection via endoscopy on days -3, 12, and 26. Patients also receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, and 29, and undergo radiation therapy on Monday through Friday beginning day 1 for 28 fractions over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 and 6-8 weeks, then every 3 months for 2 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02213133 -
Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas
|
Phase 2 | |
| Not yet recruiting |
NCT04533321 -
A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma
|
Phase 2 | |
| Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
| Active, not recruiting |
NCT01232374 -
Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
| Withdrawn |
NCT01148082 -
School Response to Families Who Have Children With Cancer
|
N/A | |
| Completed |
NCT01208883 -
A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT01089803 -
Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
|
N/A | |
| Terminated |
NCT00707655 -
Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy
|
Phase 1/Phase 2 | |
| Completed |
NCT01127737 -
Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
|
N/A | |
| Completed |
NCT00793169 -
Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
|
||
| Completed |
NCT00586040 -
Photochemical Tissue Bonding
|
Phase 2 | |
| Completed |
NCT00409565 -
A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT00176267 -
Paclitaxel, Carboplatin And Low Dose Radiation As Induction Therapy In Locally Advanced Head And Neck Cancer
|
Phase 2 | |
| Terminated |
NCT04685798 -
Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
|
N/A | |
| Recruiting |
NCT04370587 -
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04475952 -
Early Diagnosis of Upper Digestive Tract Disease
|
||
| Recruiting |
NCT04435938 -
A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck
|
Phase 2 | |
| Not yet recruiting |
NCT05852665 -
Buccal Cancer Resection Ultrasound Guided
|
N/A | |
| Recruiting |
NCT05048459 -
Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease
|
N/A | |
| Suspended |
NCT03952585 -
De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
|
Phase 2/Phase 3 |