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

Malignant Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01632696
• Other study ID #: PPHM 1201
• Status: Terminated
• Phase: Early Phase 1
• First received: June 12, 2012
• Last updated: July 7, 2017
• Start date: June 2012
• Est. completion date: May 2016

Study information

• Verified date: July 2017
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tumor Imaging of I-124 PGN65 in Solid Tumors

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Solid Tumor

Intervention

Drug:
• I-124 PGN650 for PET/CT
I-124 PGN650 for PET/CT Day 1, Day 2 and 3.

Locations

Country	Name	City	State
United States	Washington University School of Medicine, Siteman Cancer Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the intensity and distribution in critical and non-critical organs.		Day 1
Primary	To estimate the intensity and distribution in critical and non-critical organs.		Day 2
Primary	To estimate the intensity and distribution in critical and non-critical organs.		Day 3
Secondary	The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent.		Day 1, Day 2 and Day 3
Secondary	Demonstrate the safety of tumor imaging in patients with solid cancers.		Day 1, Day 2 and Day 3