This study is NOT currently recruiting participants.
Number
000462-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: No longer recruiting/follow-up only Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Fetuses;Neonates;Pregnant Women;Children
Keywords
laser system; cetuximab conjugate
Recruitment Keyword(s)
None
Condition(s)
Head and Neck Squamous Cell Carcinoma; Cutaneous Squamous Cell Carcinoma
Investigational Drug(s)
ASP-1929 PIT690 Laser System
Investigational Device(s)
Intervention(s)
Drug: ASP-1929 Procedure/Surgery: Photoimmunotherapy
Supporting Site
National Cancer Institute
Head and neck and cutaneous squamous cell carcinoma (HNSCC and cuSCC) are two of the most frequent types of cancers. cuSCC occurs in the skin covering the head and neck region. Researchers want to see if a new treatment can be used for these cancers.
Objective:
To learn if a new treatment, called photoimmunotherapy, combined with a novel drug can treat HNSCC and cuSCC.
Eligibility:
Adults ages 18 and older who have HNSCC or cuSCC.
Design:
Participants will be screened with:
Medical history
Physical exam
Electrocardiogram (to measure the heart s electrical activity)
Blood and urine samples
CT or MRI scans of their tumor. They may receive a contrast agent to enhance the images.
Tumor photographs, if needed
Tumor biopsy, if needed
During treatment and follow-up, participants will repeat some screening tests.
Participants will be admitted to the hospital for 3 days.
Day 1: Participants will receive the study drug through a needle inserted into an arm vein.
Day 2: Participants will have a tumor biopsy. Then a red light will be focused on their tumor for 5 minutes. A specialized camera will take images of their tumor. Participants may receive anesthesia.
Day 3: Participants will have a biopsy and an F-18 FDG PET/CT scan of their tumor. They will receive a radioactive tracer through a vein.
Approximately two weeks later, participants will have surgery to remove their tumor.
Participants will have a follow-up visit 30 days after surgery, then every 3 months for 12 months. After that, they will be contacted by phone every 3 months for 12 months.
Participation will last for about 2 years.
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INCLUSION CRITERIA: Patients must meet all the following criteria to be eligible for study participation: -Provide written informed consent. -Male or female >= 18 years of age at the time of informed consent. -Documentation of histologically confirmed, resectable (by standard of care surgery), primary or recurrent locoregional HNSCC or cuSCC. Verification of the diagnoses of SCC by the NIH Laboratory of Pathology will not be required if SCC is diagnosed by a CLIA-certified laboratory. Note: For patients with HNSCC, tumor locations must be in the oropharynx, oral cavity, sinonasal tract, hypopharynx, or larynx. Patients may not have a primary tumor site of nasopharynx (any histology). -At least one tumor lesion accessible for ASP-1929 PIT illumination that is ALSO amenable to imaging with the Fluorescence Imaging System camera (must be within 0.5 cm and no more than 3 cm depth to the skin or mucosal surface, with the longest diameter less than 5 cm as judged by pre-treatment imaging or examination) and radiographically measurable by RECIST 1.1, as assessed by the Investigator. --Note: ---All ASP-1929 PIT-accessible lesions within the head and neck region will be illuminated but not necessarily imaged with the Fluorescence Imaging System camera. ---Those lesions not assessable by radiographic imaging may be assessed by physical exam, measured by caliper, and documented by photography. ---Lesions located in a previously irradiated area are considered measurable if progression has been demonstrated. -Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of screening. -Adequate organ function laboratory values as described below (all screening labs should be performed <= 14 days of Day 1): --Hematology: Adequate bone marrow function as shown by absolute neutrophil count >= 1.5 x 10^9/L, platelets >=100 x 10^9/L, hemoglobin >= 9 g/dL. Patients who have received a transfusion and/or growth factors are eligible if hemoglobin is stable and at the target level. Transfusions and growth factors must not be used within 2 weeks of administration of study drug to meet these requirements. --Hepatic: Alkaline phosphatase < 2 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase < 3 times the ULN (<= 5 times the ULN for patients with liver metastases), and total serum bilirubin < 2 mg/dL (unless the patient has Gilbert s disease). --Renal: estimated glomerular filtration rate (GFR) >= 60 mL/min/1.73m2 to be calculated per the CKD-EPI equation below: GFR = 141 * min (Scr/k,1)a * max(Scr/k, 1)^-1.209 * 0.993^Age * 1.018 [if female] *1.159 (if Black) Note: Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1. --Coagulation: International Normalized Ratio or Prothrombin Time (PT) <= 1.5 times the ULN unless patient is receiving anticoagulant therapy as long as PT or Partial Thromboplastin Time is within therapeutic range of intended use of anticoagulants. -Female patients of childbearing potential must not be pregnant (confirmed by negative pregnancy test [urine or serum] at screening) or breastfeeding and must be willing to use a method of highly effective birth control, or practice abstinence throughout the study and for 60 days after the last dose of ASP-1929. Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. -Male patients must be sterile or agree to use an adequate method of contraception or practice abstinence throughout the study and for 60 days after the last dose of ASP-1929. -Provide fresh tumor biopsy at screening. Patients for whom a fresh screening biopsy cannot be obtained (eg, inaccessible or patient safety concern) may submit an archival sample provided it has been collected within <= 3 months of enrollment and no intervening anticancer treatment has occurred within that timeframe or upon agreement from the Sponsor. EXCLUSION CRITERIA: Patients will be excluded if any of the following criteria apply: -Receiving any other investigational agents or who have received local (including radiotherapy) or systemic treatment for cancer (chemotherapy, immunotherapy, any systemic investigational therapy, or EGFR-directed therapy) within 4 weeks before ASP-1929 PIT treatment. Note: Patients will be permitted to continue taking routine or necessary medications except for photosensitizing medications. -History of significant (>= Grade 3) infusion reaction to anti-EGFR antibodies. -History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASP-1929, or other agents used in study. -Require use of photosensitizing medications. Note: Photosensitizing medications must be discontinued 30 days before ASP-1929 PIT treatment. -Tumor invading major blood vessel unless the vessel has been embolized or surgically ligated to prevent hemorrhage; must not have involvement of the common or internal carotid arteries defined as invasion, encasement or direct contact (lack of a radiographically visible plane between the tumor and carotid artery). Decision to exclude will be determined by the Investigator. -Tumors inappropriate for ASP-1929 PIT treatment, including those in the brain or dura, with perineural involvement at the skull base, CNS disease, or disease in the orbit (if the eye has been previously removed, consult with Medical Monitor before excluding). Decision to exclude will be determined by Investigator. -History of distant metastatic disease (M1) based on standard of care imaging. -Any contraindications for CT or 18FDG PET/CT imaging. -Weight > 350 pounds (weight limit for scanner table), or unable to fit within the imaging gantry. -Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment cycle exposing the patient to high-intensity light (eg, eye examinations, surgical procedures) that are unrelated to ASP-1929 PIT treatment, the disease under study, or the study overall. -Diagnosed and/or treated for additional malignancy within 3 years before study Day 1, except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer treated with complete surgical resection and with no evidence of disease may be eligible based on discussion with the Medical Monitor. -Known history of testing positive for human immunodeficiency virus or acquired immunodeficiency syndrome-related illness. -Known infection or detection of active Hepatitis B (eg, HBsAg positive), Hepatitis C (eg, RNA [qualitative]), or SARS-CoV-2 (qualitative). -Received a live, attenuated vaccine within 4 weeks before Day 1 or anticipation of receiving a live, attenuated vaccine will be required during the study (based on known medical history). Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist (Registered Trademark)) are live attenuated vaccines, and are not allowed. -Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. -Major surgery or significant traumatic injury within 4 weeks of study Day 1, or anticipation of the need for major surgery that is unrelated to study intervention during the study. Note: If patient has had major surgery, they must have recovered adequately from the toxicity and/or complications before study Day 1. -Currently participating or participated in a study of any investigational agent or used any investigational device within 4 weeks of study Day 1. -Unwilling or unable to follow protocol requirements. -Any other condition which, in the Investigator s opinion, deems the patient an unsuitable candidate to receive ASP-1929 and/or be exposed to illumination, may affect the interpretation of the results, or render the patient at high risk from treatment complications. -Active infection requiring systemic therapies such as antibiotic, antifungal, or antiviral intervention which in the opinion of the Investigator precludes the patient from participating in the clinical trial.
Patients must meet all the following criteria to be eligible for study participation:
-Provide written informed consent.
-Male or female >= 18 years of age at the time of informed consent.
-Documentation of histologically confirmed, resectable (by standard of care surgery), primary or recurrent locoregional HNSCC or cuSCC. Verification of the diagnoses of SCC by the NIH Laboratory of Pathology will not be required if SCC is diagnosed by a CLIA-certified laboratory.
Note: For patients with HNSCC, tumor locations must be in the oropharynx, oral cavity, sinonasal tract, hypopharynx, or larynx. Patients may not have a primary tumor site of nasopharynx (any histology).
-At least one tumor lesion accessible for ASP-1929 PIT illumination that is ALSO amenable to imaging with the Fluorescence Imaging System camera (must be within 0.5 cm and no more than 3 cm depth to the skin or mucosal surface, with the longest diameter less than 5 cm as judged by pre-treatment imaging or examination) and radiographically measurable by RECIST 1.1, as assessed by the Investigator.
--Note:
---All ASP-1929 PIT-accessible lesions within the head and neck region will be illuminated but not necessarily imaged with the Fluorescence Imaging System camera.
---Those lesions not assessable by radiographic imaging may be assessed by physical exam, measured by caliper, and documented by photography.
---Lesions located in a previously irradiated area are considered measurable if progression has been demonstrated.
-Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of screening.
-Adequate organ function laboratory values as described below (all screening labs should be performed <= 14 days of Day 1):
--Hematology: Adequate bone marrow function as shown by absolute neutrophil count >= 1.5 x 10^9/L, platelets >=100 x 10^9/L, hemoglobin >= 9 g/dL. Patients who have received a transfusion and/or growth factors are eligible if hemoglobin is stable and at the target level. Transfusions and growth factors must not be used within 2 weeks of administration of study drug to meet these requirements.
--Hepatic: Alkaline phosphatase < 2 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase < 3 times the ULN (<= 5 times the ULN for patients with liver metastases), and total serum bilirubin < 2 mg/dL (unless the patient has Gilbert s disease).
--Renal: estimated glomerular filtration rate (GFR) >= 60 mL/min/1.73m2 to be calculated per the CKD-EPI equation below:
GFR = 141 * min (Scr/k,1)a * max(Scr/k, 1)^-1.209 * 0.993^Age * 1.018 [if female] *1.159 (if Black)
Note: Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1.
--Coagulation: International Normalized Ratio or Prothrombin Time (PT) <= 1.5 times the ULN unless patient is receiving anticoagulant therapy as long as PT or Partial Thromboplastin Time is within therapeutic range of intended use of anticoagulants.
-Female patients of childbearing potential must not be pregnant (confirmed by negative pregnancy test [urine or serum] at screening) or breastfeeding and must be willing to use a method of highly effective birth control, or practice abstinence throughout the study and for 60 days after the last dose of ASP-1929. Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
-Male patients must be sterile or agree to use an adequate method of contraception or practice abstinence throughout the study and for 60 days after the last dose of ASP-1929.
-Provide fresh tumor biopsy at screening. Patients for whom a fresh screening biopsy cannot be obtained (eg, inaccessible or patient safety concern) may submit an archival sample provided it has been collected within <= 3 months of enrollment and no intervening anticancer treatment has occurred within that timeframe or upon agreement from the Sponsor.
EXCLUSION CRITERIA:
Patients will be excluded if any of the following criteria apply:
-Receiving any other investigational agents or who have received local (including radiotherapy) or systemic treatment for cancer (chemotherapy, immunotherapy, any systemic investigational therapy, or EGFR-directed therapy) within 4 weeks before ASP-1929 PIT treatment.
Note: Patients will be permitted to continue taking routine or necessary medications except for photosensitizing medications.
-History of significant (>= Grade 3) infusion reaction to anti-EGFR antibodies.
-History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASP-1929, or other agents used in study.
-Require use of photosensitizing medications.
Note: Photosensitizing medications must be discontinued 30 days before ASP-1929 PIT treatment.
-Tumor invading major blood vessel unless the vessel has been embolized or surgically ligated to prevent hemorrhage; must not have involvement of the common or internal carotid arteries defined as invasion, encasement or direct contact (lack of a radiographically visible plane between the tumor and carotid artery). Decision to exclude will be determined by the Investigator.
-Tumors inappropriate for ASP-1929 PIT treatment, including those in the brain or dura, with perineural involvement at the skull base, CNS disease, or disease in the orbit (if the eye has been previously removed, consult with Medical Monitor before excluding). Decision to exclude will be determined by Investigator.
-History of distant metastatic disease (M1) based on standard of care imaging.
-Any contraindications for CT or 18FDG PET/CT imaging.
-Weight > 350 pounds (weight limit for scanner table), or unable to fit within the imaging gantry.
-Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment cycle exposing the patient to high-intensity light (eg, eye examinations, surgical procedures) that are unrelated to ASP-1929 PIT treatment, the disease under study, or the study overall.
-Diagnosed and/or treated for additional malignancy within 3 years before study Day 1, except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer treated with complete surgical resection and with no evidence of disease may be eligible based on discussion with the Medical Monitor.
-Known history of testing positive for human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
-Known infection or detection of active Hepatitis B (eg, HBsAg positive), Hepatitis C (eg, RNA [qualitative]), or SARS-CoV-2 (qualitative).
-Received a live, attenuated vaccine within 4 weeks before Day 1 or anticipation of receiving a live, attenuated vaccine will be required during the study (based on known medical history).
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist (Registered Trademark)) are live attenuated vaccines, and are not allowed.
-Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
-Major surgery or significant traumatic injury within 4 weeks of study Day 1, or anticipation of the need for major surgery that is unrelated to study intervention during the study.
Note: If patient has had major surgery, they must have recovered adequately from the toxicity and/or complications before study Day 1.
-Currently participating or participated in a study of any investigational agent or used any investigational device within 4 weeks of study Day 1.
-Unwilling or unable to follow protocol requirements.
-Any other condition which, in the Investigator s opinion, deems the patient an unsuitable candidate to receive ASP-1929 and/or be exposed to illumination, may affect the interpretation of the results, or render the patient at high risk from treatment complications.
-Active infection requiring systemic therapies such as antibiotic, antifungal, or antiviral intervention which in the opinion of the Investigator precludes the patient from participating in the clinical trial.
Principal Investigator
Referral Contact
For more information: