Small Cell Lung Cancer, Small Cell Lung Carcinoma
Conditions
Keywords
Small cell lung cancer, Small Cell Lung Carcinoma, 89Zr-DFO-SC16.56, 19-292, Memorial Sloan Kettering Cancer Center
Brief summary
The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.
Interventions
DRUG89Zr-DFO-SC16.56
Injection of 2 mCi of 89Zr-DFO-SC16.56 for Phase I participants. Dose for Phase II will be determined by results from Phase I.
DRUGSC16.56, Phase I, Cohort 2
7.5mg
DRUGSC16.56, Phase I, Cohort 3
22.5mg
DRUGSC16.56, Phase II
Dose for Phase II will be determined by results from Phase I.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject Inclusion Criteria for Adult population * Signed, informed consent * Age 18 or more years * Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin; or other types of neuroendocrine tumor OR Histologically confirmed prostate cancer, with suspected or confirmed NEPC based upon clinical assays obtained prior to the trial OR Histologically confirmed or suspected primary brain neoplasm OR Desmoplastic small round cell tumors, osteosarcoma, Ewing's sarcoma, rabdomyosarcoma, Wilms tumors, hepatoblastomas, rhabdoid tumors and neuroblastoma patients * At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR * Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR * MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks * ECOG performance status 0 to 2 * Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential * Available archival tumor specimen suitable for DLL3 IHC or clinician already has plans to obtain tumor specimen as part of standard of care (unrelated to patient participation in 19-292) which will yield sufficient tumor specimen to allow for DLL3 IHC * For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET/CT guided biopsy3 as described in section 9.3. 1. Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the PI's discretion. 2. Criterion is intended to demonstrate presence of imageable disease. A low-dose CT (e.g. from a PET/CT scan) may be used at PI's discretion. 3. While willingness to undergo the biopsy is required if archival tissue is not available, PET/CT guided biopsy is not a mandatory study assessment. As described in section 9.3, the guided biopsy may be waived at the discretion of the principal investigator if the DLL3 PET/CT reveals no sites of DLL3 tracer-avid tumor or if the principal investigator deems itis not in the best interest of the patient, according to best clinical judgement. The pediatric population would not be approached for an optional PET/CT-guided biopsy Subject Inclusion Criteria for Pediatric population * Signed, informed consent * Age 4 or more years * High risk neuroblastoma patients * At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks * ECOG performance status 0 to 2 * Performance Status: Subjects must have a Lansky (\<16 years) of at least 40 * Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential
Exclusion criteria
Subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participants | Up to 12 months | The PET and blood data are used to quantify tracer-biodistribution, measuring the amount of radioactivity present in the blood and bodily regions-of-interest |
| Phase I: Safety of 89Zr- DFO-SC16.56 PET/CT imaging in cancer patients by evaluating toxicities | up to 12 months | 89Zr- DFO-SC16.56 PET/CT will be considered safe if there are no possibly probably, or definitely related grade 3 or higher toxicities (except allergic reactions) among the patients enrolled in the phase I portion |
| Phase II: Correlation between tumor uptake of 89Zr- DFO-SC16.56 with expression of DLL3 | Up to 12 months | This is determined by immunohistochemistry and quantitative mass spectrometry. |
Countries
United States
Contacts
CONTACTMark P Dunphy, DO
CONTACTCharles Rudin, MD, PhD
PRINCIPAL_INVESTIGATORMark P Dunphy, DO
Memorial Sloan Kettering Cancer Center
Outcome results
None listed