Esophagogastric Cancer Clinical Trial
Official title:
Pilot Trial of PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer
NCT number | NCT02023996 |
Other study ID # | 13-165 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2013 |
Est. completion date | June 27, 2023 |
Verified date | June 2023 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is divided into two groups. The purpose of the first group (Group 1) was to find the optimal time for taking pictures after injection of 89Zr-DFO-trastuzumab, to see how long it stayed in the blood, and to see how well it was tolerated. From what the investigators have learned from Group 1, patients in Group 2 no longer need serial scans or serial blood draws. For Group 2, the patient will receive the injection of 89Zr-DFO-trastuzumab and will be monitored following the injection. The patient will be asked to return for a picture 5-8 days after injection to determine how well the study drug attaches to your tumor and how well it is tolerated
Status | Completed |
Enrollment | 36 |
Est. completion date | June 27, 2023 |
Est. primary completion date | June 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Registered patient at MSKCC - Age =18 years - Pathologically or cytologically confirmed metastatic or primary esophagogastric cancer HER2 positive status by FISH or IHC as currently being implemented for patients with esophagogastric cancer. HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH (=2.0) - Measurable or evaluable disease, lesions that have not been previously radiated, with clinically indicated imaging evaluation performed within 4 weeks prior to study entry (CT, MRI, FDG PET or bone scan). Patients requiring concurrent radiation treatment are not eligible unless additional lesions that are not being irradiated and are assessable for targeting are present. - Karnofsky Performance Score = 60 - Ability to understand and willingness to sign informed consent - Negative pregnancy test, to be performed on female patients of childbearing potential within 1week before administration of radioactive material. - Life expectancy of at least three (3) months. - Willingness to use birth control while on study. - The patients will be asked to consent to provide access to data obtained from molecular analysis that has been done on archived tumor tissue that will be correlated with 89Zr-DFO-trastuzumab imaging results. - Concurrent therapy will be allowed. Exclusion Criteria: - Inability to lie still for the duration of the scanning procedure. - Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or Desferroxamine (DFO) or trastuzumab) - Patients who have received trastuzumab must have at least a washout period for trastuzumab of 14 days, this will not apply to 89Zr-DFO-trastuzumab repeat, post treatment assessment where patients may be receiving trastuzumab. - HIV positive or active hepatitis. - History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to study entry - Hematologic - Platelets <50K/mcL - ANC <1.0 K/mcL - Hepatic laboratory values - Bilirubin >2 x ULN (institutional upper limits of normal), with exception of patients with Gilberts disease. AST/ALT >2.5 x ULN (institutional upper limits of normal); >5 x ULN if liver metastasis - Renal laboratory values - Estimated GFR (eGFR) < 30mL/min/1.73m2 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity | (CTCAE v4) Incidence and nature and severity of adverse events; and change in vital signs and clinical laboratory results. Incidence and severity of adverse events will be summarized with descriptive statistics. | 2 years | |
Primary | feasibility | Antibody imaging is considered feasible if 70% of the patients are antibody-imaging positive. Antibody imaging will be considered feasible if 7 or more of the 10 patients in the first cohort are antibody-imaging-positive.We will also require that none of these patients experience severe toxicity attributable to the initial antibody. | 2 years | |
Secondary | metabolite analysis | Samples will be obtained just prior to injection of the 89Zr DFO-trastuzumab tracer this sample will be banked at -80degree C for future testing for immune response (HAHA) if altered biodistribution is observed., and at 5 ± 2 minutes, 15 ± 5, 30 ± 9, 60 ± 19 minutes, and 120 - 240 minutes after the injection of the tracer 1, and at the time of each subsequent day of imaging. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05544929 -
A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT05612048 -
A Study of Tooth Erosion in People With Esophagogastric Cancer
|
N/A | |
Completed |
NCT04161781 -
A Study of PET Scans With the Radioactive Tracer 18F-BMS-986229 in Patients With Esophageal, Stomach, or Gastroesophageal Junction Cancer
|
||
Completed |
NCT01803282 -
Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05796102 -
PET-MRI Esophagus Feasibility Study
|
N/A | |
Recruiting |
NCT04656041 -
Folfox+Irinotecan+Chemort In Esophageal Cancer
|
Phase 2 | |
Withdrawn |
NCT02296671 -
Personalized Therapy for Esophagogastric Cancer Using Thymidylate Synthase Genetic Markers
|
Phase 2 | |
Active, not recruiting |
NCT04757363 -
A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer
|
Phase 2 | |
Recruiting |
NCT05117931 -
A Study of Amivantamab in People With Esophagogastric Cancer
|
Phase 2 | |
Not yet recruiting |
NCT03760289 -
DKN-01/Atezolizumab as Second Line Treatment of biliarY Tract Cancer and in combiNAtion or Not With Paclitaxel as Second Line treatMent of esophagogastrIC Cancer
|
Phase 2 | |
Completed |
NCT01167114 -
STA-9090 in Previously Treated Patients With Advanced Esophagogastric Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03133650 -
A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing
|
Phase 1 |