Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

This study is being conducted to see if LUM015 can be safely given to human patients before
surgery at a dose that allows the removed tumor tissue to be identified when imaged by the
LUM imaging device.

The first 6 subjects will receive an intravenous injection of LUM015 intraoperatively with a
dose of either 1.0 mg/kg or 1.5 mg/kg. The first three subjects will receive a dose of 1.0
mg/kg and if there are no adverse events the next three subject will receive the increased
dose of 1.5 mg/kg. LUM015 will be given through a vein in the arm.

When the final dose of LUM015 has been determined, 12 additional subjects will be given that
final dose.

The sequence of events during the surgical procedure will vary based on the standard of care
used by the surgeon. Study treatment ends when the surgery is completed. All patients will
continue their enrollment in the study until their first follow-up visit and they will
continue to be followed until the medical team determines no further surgical intervention is
required. Patients with adverse events that are determined to be possibly related to the LUM
Imaging System will be followed until resolution or stabilization of the adverse event.

Inclusion Criteria:

- Subjects must have histologically or cytologically confirmed metastases to the
peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to
surgery.

- Subjects must be scheduled for surgical resection.

- Age of 18 years or older.

- Subjects must be able and willing to follow study procedures and instructions.

- Subjects must have received and signed an informed consent form.

- Subjects must be otherwise healthy except for the diagnosis of cancer, as per the
criteria listed below.

- Subjects must have normal organ and marrow function as defined as:

- Leukocytes > 3,000/mcL

- Absolute neutrophil count > 1,500/mcL

- Platelets > 100,000/mcL

- total bilirubin within normal institutional limits

- AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits or creatinine clearance > 60
mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.

- Subjects with ECOG performance status of 0 or 1.

Exclusion Criteria:

- Subjects who are pregnant or nursing at the time of diagnosis.

- Subjects who are sexually active and not willing/able to use medically acceptable
forms of contraception (hormonal or barrier method of birth control, abstinence) upon
entering the study and for 60 days after injection of LUM015.

- Subjects who have taken an investigational drug within 30 days of enrollment.

- Subjects who have not recovered from adverse events due to other pharmaceutical or
diagnostic agents.

- Subjects with uncontrolled hypertension defined as persistent systolic blood pressure
> 180 mm Hg, or diastolic blood pressure > 100 mm Hg; those subjects with known HTN
should be under these values while under pharmaceutical therapy.

- History of allergic reaction attributed to drugs containing polyethylene glycol (PEG).

- History of allergic reaction to any oral or intravenous contrast agents.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or
psychiatric illness/social situations that would limit compliance with study
requirements.

- HIV-positive individuals on combination antiretroviral therapy are ineligible.

- Any subject for whom the investigator feels participation is not in the best interest
of the subject.