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

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ClinicalTrials.gov Identifier: NCT01632696
Recruitment Status : Terminated (Sponsor decision)
First Posted : July 3, 2012
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals

Brief Summary:
Tumor Imaging of I-124 PGN65 in Solid Tumors

Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Drug: I-124 PGN650 for PET/CT Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
Study Start Date : June 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To estimate the intensity and distribution in critical and non-critical organs. [ Time Frame: Day 1 ]
  2. To estimate the intensity and distribution in critical and non-critical organs. [ Time Frame: Day 2 ]
  3. To estimate the intensity and distribution in critical and non-critical organs. [ Time Frame: Day 3 ]

Secondary Outcome Measures :
  1. The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent. [ Time Frame: Day 1, Day 2 and Day 3 ]
  2. Demonstrate the safety of tumor imaging in patients with solid cancers. [ Time Frame: Day 1, Day 2 and Day 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632696


Locations
United States, Missouri
Washington University School of Medicine, Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Peregrine Pharmaceuticals
Investigators
Principal Investigator: Farrokh Dehsashti, M.D. Washington University School of Medicine

Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01632696     History of Changes
Other Study ID Numbers: PPHM 1201
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

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