PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study

The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body & inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. The results of this study will help researchers (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting tumors with scanner machines.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Hodgkin's Lymphoma; Myeloma; Active Solid Malignancy
• Intervention / Treatment: Drug: PET Imaging using 124 IPUH71

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma (histology confirmed by MSKCC Department of Pathology)
• Disease is measurable or evaluable as defined by RECIST (1.1 or original version) or other tumor response criteria from an MSKCC IRB-approved clinical research protocol.
• This does not apply to patients with myeloproliferative neoplasm. The presence of active myeloproliferative neoplasm will be determined by applicable disease specific diagnostic criteria and patient assessment by the patient's oncologist and trial investigators (eg, manifestations of active MPN such as splenomegaly, abnormal blood counts, etc).
• Age between 18-90
• Negative serum pregnancy test for females of childbearing age (11-55 years) and/or lack child-bearing potential
• No breast-feeding

Exclusion Criteria:

• Previous allergic reaction to contrast medium.
• Hypersensitivity to iodide products.
• Known hyperthyroidism

Hepatic:

• Bilirubin > 1.5 x institutional upper limit of normal (ULN)
• AST/ALT >2.5 x ULN
• Albumin < 2 g/dl
• GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN. Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min.
• Positive serum pregnancy test for females
• Acute major illness (e.g., infection, unstable cardiovascular condition, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PET Imaging Using 124 IPUH71; Patients will receive an injection of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71, followed by serial PET scanning and blood draws, over a period of 3 days. Optional with a fourth day of PET scanning is to be pursued, in willing patients.

Drug: PET Imaging using 124 IPUH71; A dose of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71 will be administered intravenously with the patient at rest. 124I-PUH71 scans will be performed at immediately and/or 3-4 hours, 20-24 hours, and 40-80 hours after injection of the radiotracer. Optionally, in willing patients scans will be performed 160-200 hours (~7-8 days) after injection of the radiotracer. At each time-point, a 45-60 minute axial body image is acquired. Images will be acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. A 30-45 minute scanning timeperiod is typical for clinical PET studies.; Other Names: Blood will be drawn at the multiple time points for pharmacokinetic & metabolite; analyses of 124I-PUH71. We anticipate these time points to be: approximately 10; minutes, 20 minutes, 30 minutes, 1-2 H, and 3-4 H, post-injection. Blood; samples will be obtained in the PET imaging suite.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the pharmacokinetics	of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the metabolism	of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.	2 years
To study the biodistribution	of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.	2 years
To study the radiation dosimetry	of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Samus Therapeutics
• Investigators: Principal Investigator: Mark Dunphy, DO, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 29, 2010
• First Submitted That Met QC Criteria: January 3, 2011
• First Posted (Estimated): January 4, 2011

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: PET Scan; 124I-PUH71; 10-139
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: 10-139