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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Samus Therapeutics

Criteria

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.)