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

ConditionsSmall Cell Lung CancerSmall Cell Lung Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of anaphylactic reaction to humanized 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 89Zr-DFO-SC16.56

    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

    Drug

    7.5mg

  • SC16.56, Phase I, Cohort 3

    Drug

    22.5mg

  • SC16.56, Phase II

    Drug

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

Treatment groups

105 Participants
are divided into 2 treatment groups
Group A: Phase IExperimental treatment 3 interventions
Group B: Phase IIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participants

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

Time frame
Up to 12 months
2

Phase I: Safety of 89Zr- DFO-SC16.56 PET/CT imaging in cancer patients by evaluating toxicities

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

Time frame
up to 12 months
3

Phase II: Correlation between tumor uptake of 89Zr- DFO-SC16.56 with expression of DLL3

This is determined by immunohistochemistry and quantitative mass spectrometry.

Time frame
Up to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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