TheranosticTrials.org

Clinical Trial · NCT01320059

Study of 18F-Fluoro-PEG6-IPQA

Overview

The goal of this clinical research study is to learn if an imaging solution called 18F-PEG6-IPQA can help to find tumors when used in positron emission tomography (PET) scans. The safety of the solution and how the solution is processed by your body will also be studied.

Sponsor

MD Anderson Cancer Center

Phase

Phase 1

Contacts

Donald Podoloff, MD,BA (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01320059

Drug / Compound

PEG6-IPQA

Isotope(s):
Target(s):
  • EGFR
Ligand Class: Small Molecules
Linker: PEG6

Eligibility

Inclusion

  • Patients should be potential candidates for therapy with an EGFR tyrosine kinase inhibitor or with an anti-EGFR monoclonal antibody by clinical criteria.
  • Patients with brain metastases are eligible provided they meet all other eligibility criteria and do not require corticosteroids or enzyme-inducing anticonvulsants and provided it is felt clinically that they will not require radiotherapy in the three (3) weeks subsequent to their participation in the study
  • Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. The patient, if a man, agrees to use effective contraception or abstinence
  • Patients should have clinical characteristics that would suggest an increased probability of benefit from an EGFR inhibitor. Specifically, they should have known EGFR mutations or high gene copy number.
  • The patient must be considered legally capable of providing his or her own consent for participation in this study
  • Patients should be Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients should have pathologically or cytologically confirmed Stage IV non-small cell lung cancer with clinical or radiological evidence that it is not amenable to therapy with curative intent. Prior EGFR tyrosine kinase inhibition (TKI) therapy is permitted but not required.
  • Patients should have at least one tumor deposit that is \> 1.0 cm in diameter, and that is amenable to imaging

Exclusion

  • Radiotherapy, chemotherapy or any investigational agent within the previous 2 weeks of administrating 18F-PEG6-IPQA for PET/CT imaging.
  • Any condition that is unstable or could jeopardize the safety of the patient and his or her compliance in the study, in the investigator's judgment
  • 10\. Hemoglobin \< 8 g/dL, absolute neutrophil count \< 1,500/mm3, platelet count \<100,000/mm3
  • Pregnant or nursing
  • Squamous cell, large cell undifferentiated, neuroendocrine or small cell undifferentiated carcinoma of the lung
  • Potentially life-threatening arrhythmia; myocardial infarct within the previous 3 months; unstable angina, or angina at rest; congestive heart failure (New York Heart Association Functional Classification class II or worse), uncontrolled hypertension (systolic BP \> 160 or diastolic BP \>100).
  • Active acute infection (i.e. currently treated with antibiotics). Patients with chronic infections such as hepatitis B or C, mycobacterium avium or similar infections will be eligible provided they meet all other eligibility criteria.
  • Serum creatinine \>1.5 x upper limit of normal (ULN), bilirubin \>1.5 x ULN, AST \> 3 x ULN
  • Oxygen saturation \<90% on room air
  • Clinical requirement for systemic corticosteroids for control of cerebral edema or for enzyme-inducing anticonvulsants. (Inhaled steroids and systemic steroids for chronic obstructive pulmonary disease (COPD) are permitted).
  • Thoracic or abdominal surgery within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT imaging.
  • A non-investigational targeted agent within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT imaging.
  • Physical inability to undergo a scanning procedure (e.g., inability to lie flat for the required period of time - three sessions of roughly an hour each with ten minutes' rest in between)
  • A tumor that is known to have a K-ras mutation