PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-11

Study Completion Date

2026-06-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Small Cell Lung Cancer Small Cell Lung Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Phase I

Up to 12 participants with tumors that are found to be \>/= 50% positive for DLL3 by IHC

Group Type EXPERIMENTAL

89Zr-DFO-SC16.56

Intervention Type DRUG

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.

SC16.56, Phase I, Cohort 2

Intervention Type DRUG

7.5mg

SC16.56, Phase I, Cohort 3

Intervention Type DRUG

22.5mg

Phase II

Up to 18 participants with tumors that are found to be \>/= 50% positive for DLL3 by IHC

Group Type EXPERIMENTAL

89Zr-DFO-SC16.56

Intervention Type DRUG

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.

SC16.56, Phase II

Intervention Type DRUG

Dose for Phase II will be determined by results from Phase I.

Interventions

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89Zr-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.

Intervention Type DRUG

SC16.56, Phase I, Cohort 2

7.5mg

Intervention Type DRUG

SC16.56, Phase I, Cohort 3

22.5mg

Intervention Type DRUG

SC16.56, Phase II

Dose for Phase II will be determined by results from Phase I.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed, informed consent
* Age 4 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
* 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
* 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 or 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 with only bone metastases, a recent PET scan (FDG or PSMA-targeted) that shows tracer-avid osseous metastases, a recent MRI that shows new osseous metastases, a bone scan that shows new osseous metastases, or have recent PET or SPECT scans that demonstrate tumors that are evaluable by PET or SPECT. The scans should have been obtained in the last 8 weeks.

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 it is 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

Exclusion Criteria

* History of anaphylactic reaction to humanize or human antibodies
* Pregnant or breast feeding
* Psychiatric illness that would interfere with compliance with the study procedures
* Inability to undergo PET scan due to weight limit
* Patients who require anesthesia or monitored sedation to tolerate PET scan procedure

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No