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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Active Solid Malignancy; Non-Hodgkin's Lymphoma; Myeloma

Treatments: Drug: PET Imaging using 124 IPUH71

Study type: Interventional

Funder types: Other

Identifiers

NCT01269593

10-139

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

PET Imaging Using 124 IPUH71

Experimental group

Description:

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.

Treatment:

Drug: PET Imaging using 124 IPUH71