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An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037


Phase 0
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Squamous Cell Carcinoma, Head and Neck Cancer, Hepatic Carcinoma, Renal Cell Carcinoma

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Trial Information

An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037


[F-18]VM4-037 is being developed as a diagnostic radiopharmaceutical for PET imaging.

SMI is seeking to determine if [F-18]VM4-037 might be useful as a PET ligand for the in vivo
imaging of CA-IX levels in human tissue.

CA-IX is a very active enzyme which may acidify the extracellular microenvironment of tumor
cells in response to hypoxia. Its expression usually promotes tumor growth and invasion, and
thus impairs prognosis.

VM4-037 presents no known risks from either in vitro study in cell lines or in vivo study in
animals according to in-house preclinical investigations of this compound.

The population to be studied consists of a total of approximately sixteen (16) adult
subjects, which includes four normal, healthy volunteers and twelve cancer subjects with a
confirmed or highly suspected diagnosis of head and neck cancer, non-small cell lung cancer,
large solitary hepatic carcinoma, and renal cell carcinoma as defined by the protocol
criteria.

This initial trial will be an Exploratory, Phase 0 study designed to evaluate
biodistribution, collect baseline and tumor/background imaging data, and gather preliminary
safety data for this investigational product. The study results will be analyzed and
considered in the design of future clinical trials.

The primary objectives of this exploratory study are:

- To gain information on the bio-distribution of [F-18]VM4-037, to evaluate the PET
images of [F-18]VM4-037 for resolution and signal to background ratio for tumors, and
to determine CA-IX expression in tumor tissues by CA-IX antibody with
immunohistochemistry

- To collect safety data, and to use this eIND in order to obtain the necessary
information to file an IND (Investigational New Drug) application with the FDA (Food
and Drug Administration)

The secondary objectives for this exploratory study are:

- To begin collection of baseline imaging and metabolism data

- To gain information to improve study design for the conduct of future trials

The trial is expected to begin subject enrolment in approximately April, 2009 and end
subject participation in approximately September, 2009, depending on the rate of enrollment.

The subject is expected to attend three visits, adding up to several hours.

The Investigational Product (IP) being tested in this study is [F-18]VM4-037. The
[F-18]VM4-037 will be administered to each qualified subject via a bolus intravenous (IV)
injection. For normal volunteers, the dose will not exceed 20 mCi, as the imaging time for
dosimetry is a minimum of four hours. For cancer subjects, the dose will be closer to 10 mCi
(total imaging time for cancer subjects is about 2 hours).

The procedures for this study include the following:

Obtain Informed Consent, Assign Study Subject Number, Obtain Medical History, Perform
Eligibility Blood Labs, Take Pre-Dose Blood Sample for CA-IX Test, Perform Pre-Dose ECG,
Monitor and Collect Adverse Events, Collect Concomitant Medications, Perform Pre-Dose
Physical Exam, Perform Pre-Dose ECG, Insert IV Line, Take Pre-Dose CBC and Chemistry Blood
Labs, Take Pre-Dose Blood Sample for Metabolite Analysis (if applicable), Take Pregnancy
Test (if applicable), Take Pre-Dose Vital Signs, Prepare and Administer IP, Perform
[F-18]VM4-037 PET Imaging, Take Post-Dose Blood Samples for Metabolite Analysis (if
applicable), Take Post-Dose Vital Signs, Perform Post-dose ECGs, Collect Urine Sample and
Count for Dosimetry (normal only), Monitor Adverse Events, Collect Concomitant Medications,
Perform Physical Exam 24 hr Post-Dose, Take Blood Sample for CBC and Chemistry Labs 24 hr
Post-Dose, Perform ECG 24 hr Post-Dose, Take Vital Signs 24 hr Post-Dose, Monitor and
Collect Adverse Events, Collect Concomitant Medications, [F-18]FDG PET Imaging,
Immunohistochemistry


Inclusion Criteria:



Normal Volunteers

- Subject is ≥ 18 years old at the time of investigational product administration, and
subject is male or female of any race / ethnicity

- Subject or subject's legally acceptable representative provides written informed
consent

- Subject is capable of complying with study procedures

- Subject is capable of communicating with study personnel

- Subject must have renal and hepatic functions and haematological values as defined by
laboratory results within defined ranges

Cancer Subjects

- Subject is ≥ 18 years old at the time of the investigational product administration,
and subject is a male or female of any race/ethnicity

- Subject or subject's legally acceptable representative provides written informed
consent

- Subject is capable of complying with study procedures

- Subject is capable of communicating with study personnel

- Subject must have renal and hepatic functions and haematological values as defined by
laboratory results within defined ranges

- Subject must have confirmed or highly suspected non-small cell lung cancer (local or
with metastases), squamous cell carcinoma (advanced stages) of the head and neck
whose primary origin was from oral cavity, oropharynx, hypopharynx or larynx (local
or with metastases), large solitary hepatic carcinoma (primary or metastatic), or
renal cell carcinoma (local or with metastases )

- Subject has an adequate size of tumors (≥2 cm) that should be amenable to imaging and
biopsy for immunohistochemistry assay using CA-IX and/or hypoxia biomarkers

- Subject did not have any anticancer treatment intervention between [F-18]VM4-037 scan
and sampling of biopsied tissue

- Subject is scheduled for a clinical [F-18]FDG PET scan within 14 days either prior to
or after the investigational, [F-18]VM4-037 scan (with no anticancer treatment
interventions between the two PET scans)

- Subject has a value of ≥ 60% at the time screening according to the Karnofsky
Performance Status Scale

Exclusion Criteria:

Normal Volunteers

- Subject is < 18 years old at the time of investigational product administration

- Subject is nursing

- Female subject is pregnant

- Subject is unable to remain still for duration of imaging procedure

- Subject has a significant hepatic or renal disease as defined by previous medical
history or abnormal renal and hepatic functions determined by above lab tests in
inclusion criteria

- Subject has previously received [F-18]VM4-037 at any time

- Subject has been involved in an investigative, radioactive research procedure within
the past 14 days

- Subject has any other condition or personal circumstance that, in the judgment of the
investigator, might interfere with the collection of complete data or data quality

- Subject has a history of significant prescription or non-prescription drug, or
alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives

Cancer Subjects

- Subject is < 18 years old at the time of investigational product administration

- Subject is nursing

- Female subject is pregnant

- Subject is unable to remain still for duration of imaging procedure

- Subject has significant hepatic or renal disease as defined by previous medical
history or abnormal renal and hepatic functions determined by above lab tests in
inclusion criteria

- Subject has previously received [F-18]VM4-037 at any time

- Subject has been involved in an investigative, radioactive research procedure within
the past 14 days

- Subject has any other condition or personal circumstance that, in the judgment of the
investigator, might interfere with the collection of complete data or data quality

- Subject has a history of significant prescription or non-prescription drug, or
alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives

- Subject has had an anticancer treatment intervention between [F-18]VM4-037 scan and
biopsied tissue sampling

- Subject has had an anticancer treatment intervention between [F-18]VM4-037 scan and
[F-18]FDG scan

- Subject has an inadequate tumor sites or volume (< 2 cm) to allow for PET images and
biopsy for immunohistochemistry

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug.

Outcome Time Frame:

(3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit

Safety Issue:

Yes

Principal Investigator

Michael Yu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

DVM4000

NCT ID:

NCT00884520

Start Date:

April 2009

Completion Date:

March 2010

Related Keywords:

  • Lung Cancer
  • Squamous Cell Carcinoma
  • Head and Neck Cancer
  • Hepatic Carcinoma
  • Renal Cell Carcinoma
  • [F-18]VM4-037
  • VM4-037
  • hypoxia
  • CA-IX
  • CAIX
  • carbonic anhydrase IX
  • hypoxia marker
  • lung cancer
  • renal carcinoma
  • squamous cell carcinoma
  • hepatic carcinoma
  • head and neck cancer
  • advanced stage lung cancer
  • exploratory
  • Carcinoma
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111