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

Early Phase 1

Active, not recruiting

• Conditions: Non-Hodgkin's Lymphoma; Myeloma; Active Solid Malignancy
• Interventions: Drug: PET Imaging using 124 IPUH71

• Registration Number: NCT01269593
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET Imaging Using 124 IPUH71	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States