Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Peregrine Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01632696
First received: June 12, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

Tumor Imaging of I-124 PGN65 in Solid Tumors


Condition Intervention Phase
Malignant Solid Tumour
Drug: I-124 PGN650 for PET/CT
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
  • To estimate the intensity and distribution in critical and non-critical organs. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • To estimate the intensity and distribution in critical and non-critical organs. [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • To estimate the intensity and distribution in critical and non-critical organs. [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent. [ Time Frame: Day 1, Day 2 and Day 3 ] [ Designated as safety issue: No ]
  • Demonstrate the safety of tumor imaging in patients with solid cancers. [ Time Frame: Day 1, Day 2 and Day 3 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I-124 PGN650 for PET/CT Drug: I-124 PGN650 for PET/CT
I-124 PGN650 for PET/CT Day 1, Day 2 and 3.
Other Name: I-124 PGN650

Detailed Description:

Up to 12 patients (6 men and 6 women) will be enrolled in this open-label, single-arm, tumor imaging and dosimetry study of I-124 PGN650 in solid tumors. All eligible patients who give written, informed consent and meet all inclusion criteria and no exclusion criteria, and whose laboratory results are within specified limits at the screening visit, will be enrolled. All study subjects will receive a single intravenous (IV) dose of I-124 PGN650. Study subjects will have whole body PET/CT imaging at three different timepoints with all patients having PET/CT at 0 to 60 minutes after injection of I-124 PGN650. Study subjects will then be assigned to either a 3 to 5-hour or 6 to 8-hour timepoint and either an 18 to 26 hour or 42 to 52 hour post-injection timepoint. Tumor and whole body radioactivity distribution will be measured.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Signed informed consent form.
  2. Male or female, ≥ 18 years of age.
  3. Histologically or cytologically confirmed solid tumors at any stage with at least one lesion (primary, metastatic, or recurrent) ≥ 1.5 cm in diameter documented by CT. If the lesion is located in a lymph node, the shortest diameter of the lymph node must be ≥ 1.5 cm as defined by RECIST 1.1. (Note: See Exclusion Criteria #1.)
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  5. Adequate baseline hematological and organ function, assessed by laboratory values prior to study treatment as follows: absolute neutrophil count (ANC) > 1.0 x 109/L; hemoglobin > 7 g/dL; serum creatinine < 2 x institutional upper limit of normal (IULN); aspartate transaminase (AST) < 2.5 x IULN; alanine transaminase (ALT) < 2.5 x IULN; (if liver metastases are present, ALT and AST < 5 x IULN); total bilirubin < 1.5 x IULN.
  6. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence), for the duration of study participation (i.e., from dosing day 1 until study day 8). Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  7. Patient must be willing and able to undergo the imaging studies outlined in the protocol.

Exclusion Criteria

  1. Only measureable disease (primary or metastatic) is located in or near the thyroid gland, liver, kidney, or urinary bladder.
  2. Medical conditions such as ischemic heart or lung disease that may be considered an unacceptable risk.
  3. Females who are lactating or pregnant.
  4. Persistent acute toxicities from prior anti-cancer therapy.
  5. History of hypersensitivity to iodine.
  6. Known bladder outlet obstruction.
  7. Any condition that would in the Investigator's judgment prevents compliance with the requirements of the protocol.
  8. Patients with known history of an autoimmune disease- including but not limited to: celiac disease, Crohn's disease, dermatomyositis, Grave's disease, systemic lupus erythematosus, myasthenia gravis, psoriasis, and rheumatoid arthritis.
  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: NCT01632696

Contacts
Contact: Vipin Aggarwal, MD, MPH (714) 508-6033 vaggarwal@peregrineinc.com
Contact: AJ Leyco (714) 508-6026 aleyco@peregrineinc.com

Locations
United States, Missouri
Washington University School of Medicine, Siteman Cancer Center Recruiting
St. Louis, Missouri, United States, 63110
Contact: Farrokh Dehdashti, MD    314-362-1474    dehdastif@mir.wustl.edu   
Contact: Yongjian Liu    314-362-8431    liuyo@mir.wustl.edu   
Principal Investigator: Farrokh Dehdashti, MD         
Sponsors and Collaborators
Peregrine Pharmaceuticals
  More Information

No publications provided

Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01632696     History of Changes
Other Study ID Numbers: PPHM 1201
Study First Received: June 12, 2012
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Peregrine Pharmaceuticals:
Antibodies, Monoclonal
Biologics
F(ab')2
Positron-emission tomography (PET)
Phosphatidylserine (PS)
Solid Tumors
Tumor Imaging

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014