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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-05-31

Brief Summary

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Tumor Imaging of I-124 PGN65 in Solid Tumors

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Detailed Description

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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.

Conditions

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Malignant Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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I-124 PGN650 for PET/CT

Group Type EXPERIMENTAL

I-124 PGN650 for PET/CT

Intervention Type DRUG

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

Interventions

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I-124 PGN650 for PET/CT

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

Intervention Type DRUG

Other Intervention Names

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I-124 PGN650

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent form.
2. Male or female, ≥ 18 years of age.

Exclusion Criteria

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No