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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01269593
First received: December 29, 2010
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Non-Hodgkin's Lymphoma
Myeloma
Active Solid Malignancy
Drug: PET Imaging using 124 IPUH71

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To study the pharmacokinetics [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    of 124I-PUH71 in patients with solid malignancy and/or lymphoma.


Secondary Outcome Measures:
  • To study the metabolism [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    of 124I-PUH71 in patients with solid malignancy and/or lymphoma.

  • To study the biodistribution [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    of 124I-PUH71 in patients with solid malignancy and/or lymphoma.

  • To study the radiation dosimetry [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    of 124I-PUH71 in patients with solid malignancy and/or lymphoma.


Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with solid malignancy, 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.
  • 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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269593

Contacts
Contact: Mark Dunphy, DO 212-639-8131
Contact: Gabriela Chiosis, PhD 646-888-2235

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mark Dunphy, DO    212-639-8131      
Contact: Gabriela Chiosis, PhD    646-888-2235      
Principal Investigator: Mark Dunphy, DO         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Mark Dunphy, DO Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01269593     History of Changes
Other Study ID Numbers: 10-139
Study First Received: December 29, 2010
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
PET Scan
124I-PUH71
10-139

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014