Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04391049
Other study ID # NRG-GI007
Secondary ID NCI-2020-02320NR
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 29, 2020
Est. completion date October 1, 2025

Study information

Verified date February 2024
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date October 1, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma or squamous cell carcinoma (SCC) of the esophagus or gastroesophageal junction (GEJ) within 90 days prior to registration - Gastroesophageal junction tumors must be Siewert type I/II - Required diagnostic workup for study entry: - History/physical examination prior to registration - Computed tomography (CT) of the chest/abdomen with intravenous contrast within 28 days prior to registration; If CT contrast is contraindicated magnetic resonance imaging (MRI) of the chest/abdomen without contrast is permitted - Bronchoscopy for squamous cell carcinoma (SCC) tumors that are adjacent to the airway to exclude a tracheoesophageal fistula within 42 days prior to registration - Endoscopic ultrasound (if technically feasible) within 90 days prior to registration - Whole body positron emission tomography (PET)/CT scan within 42 days prior to registration: Note: scan will be used for radiation treatment planning, in addition to ruling out metastatic disease - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 14 days prior to registration - White blood cell (WBC) = 3,000/mcL (within 14 days prior to registration) - Absolute neutrophil count = 1,500/mcL (within 14 days prior to registration) - Hemoglobin = 9 gm/dL (within 14 days prior to registration) - Platelets = 100,000/mcL (within 14 days prior to registration) - Creatinine clearance of = 50 ml/min (as calculated by Cockcroft-Gault equation) (within 14 days prior to registration) - Total bilirubin = 1.5 x upper limit of normal (ULN) (within 14 days prior to registration) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 2.5 x ULN (within 14 days prior to registration) - Patients must, in the opinion of a thoracic surgeon and/or multidisciplinary team, not be a candidate for surgery but are candidates for chemoradiation - Patients must, in the opinion of a treating gastroenterologist, have a tumor that is amenable to intratumoral injection with at least 1 mL (1 x 10^12 vp/mL) of OBP-301 and be a candidate for 3 endoscopy procedures - Female patients of child bearing potential must have a negative serum/urine pregnancy test within 14 days prior to study entry. A female not of childbearing potential is one who has undergone a hysterectomy, bilateral oophorectomy, tubal ligation, or who has had no menses for 12 consecutive months - Patients of reproductive potential must agree to use effective contraception for the duration of study treatment as well as 6 months (for women) or 12 months (for men) after the last administered injection of OBP-301. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Known acute or chronic hepatitis B or C infection (testing not required prior to study entry in patients with no known history of hepatitis B or C) - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - For patients with a history of hepatitis C virus (HCV) infection, they must (i) have been treated and cured, (ii) for patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to study entry are eligible for this trial Exclusion Criteria: - Definitive clinical or radiologic evidence of metastatic disease including: - Positive malignant cytology of the pleura, pericardium or peritoneum - Radiographic evidence of involvement of any adjacent mediastinal structure, e.g. aorta, trachea, which would increase the risk of repeated endoscopic interventions - Tracheoesophageal fistula - Radiographic evidence of distant organ involvement - Non-regional lymph nodes that cannot be contained within a radiation field - More than 1 esophageal lesion - Prior systemic chemotherapy for the study cancer - Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - Biopsy-proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula or recurrent laryngeal or phrenic nerve paralysis - For patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, a New York Heart Association functional classification 2C or worse - Uncontrolled diabetes - Infection requiring IV antibiotics at the time of registration - Patients requiring immunosuppressive medications including chronic suppressive steroid therapy (greater than the equivalent of 20 mg/day of prednisone), methotrexate, azathioprine and TNF-alpha blockers within 7 days prior to study entry - Received live vaccine within 30 days prior to registration - Received a blood transfusion, hematopoietic agent; granulocyte-colony stimulating factor (G-CSF), and/or oxygen supplementation within 7 days before the screening lab - Breast feeding females

Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Advanced Esophageal Adenocarcinoma
  • Advanced Gastroesophageal Junction Adenocarcinoma
  • Carcinoma, Squamous Cell
  • Clinical Stage II Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage III Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Esophageal Neoplasms
  • Neoplasms, Squamous Cell
  • Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Squamous Cell Cancer
  • Squamous Cell Carcinoma
  • Unresectable Gastroesophageal Junction Adenocarcinoma

Intervention

Drug:
Carboplatin
Given IV
Paclitaxel
Given IV
Radiation:
Radiation Therapy
Undergo radiation therapy
Biological:
Telomerase-specific Type 5 Adenovirus OBP-301
Given by intratumoral injection

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States City of Hope Comprehensive Cancer Center Duarte California
United States University of Kansas Clinical Research Center Fairway Kansas
United States Memorial Sloan Kettering Westchester Harrison New York
United States M D Anderson Cancer Center Houston Texas
United States University of Kansas Cancer Center Kansas City Kansas
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States City of Hope South Pasadena South Pasadena California
United States Moffitt Cancer Center Tampa Florida
United States Memorial Sloan Kettering Nassau Uniondale New York
United States City of Hope Upland Upland California
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas

Sponsors (2)

Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose Limiting Toxicity All adverse events will be graded according to Common Terminology Criteria for Adverse Events version 5.0 From start of protocol treatment until 30 days after the completion of chemoradiation
Secondary Incidence of Adverse Events Assessed using Common Terminology Criteria for Adverse Events version 5.0. Counts of all adverse events (AEs) by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm and within the subset of AEs related to treatment. No formal statistical testing will be performed on these summary data. Up to 2 years
Secondary Clinical Complete Response (cCR) If one of the OBP-301 regimens is declared to be safe, the number of cCRs will be reported. No formal statistical testing will be performed on these summary data. 6-8 weeks after completion of chemoradiation
Secondary Progression-free Survival If one of the OBP-301 regimens is declared to be safe, number of patients alive without progression will be reported. No formal statistical testing will be performed on these summary data. Time from registration to progressive disease or death, whichever occurs first, assessed up to 2 years
Secondary Overall Survival If one of the OBP-301 regimens is declared to be safe, number of patients alive will be reported. No formal statistical testing will be performed on these summary data. Time from registration to death, assessed up to 2 years
See also
  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
Completed NCT01208883 - A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer Phase 1
Withdrawn NCT01148082 - School Response to Families Who Have Children With Cancer N/A
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 NCT00586040 - Photochemical Tissue Bonding 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 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