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

Stopped early · Early Phase 1

Conditions studied: Malignant Solid Tumor

In brief

Tumor Imaging of I-124 PGN65 in Solid Tumors

Key facts

Study ID

NCT01632696

Run by

Peregrine Pharmaceuticals

People needed

11

Starts

2012-06-01

Expected to finish

2016-05-01

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form.
• Male or female, ≥ 18 years of age.
• 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.)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• 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.
• 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.
• Patient must be willing and able to undergo the imaging studies outlined in the protocol.

You may not qualify if…

• Only measureable disease (primary or metastatic) is located in or near the thyroid gland, liver, kidney, or urinary bladder.
• Medical conditions such as ischemic heart or lung disease that may be considered an unacceptable risk.
• Females who are lactating or pregnant.
• Persistent acute toxicities from prior anti-cancer therapy.
• History of hypersensitivity to iodine.
• Known bladder outlet obstruction.
• Any condition that would in the Investigator's judgment prevents compliance with the requirements of the protocol.
• 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.

Where it is running

• Washington University School of Medicine, Siteman Cancer Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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