A Pilot Study Treatment of Malignant Tumors Using [18F] Fluorodeoxyglucose (FDG)

Inclusion Criteria:

- Provision of informed consent.

- Adults 21 years and older.

- Stage IV solid cancers and stage IV lymphomas that failed to respond to two or more
regimens of standard chemotherapy.

- Life expectancy more than 3 months.

- ECOG performance status equal to or less than 2.

- Pathologically documented solid tumors and lymphoma.

- SUV in the primary tumor and/or at least one of the metastatic lesions will need to
have an SUV ratio tumor to liver at least greater than 5 and the SUV in the bladder
should not be above 100.

- Adequate bone marrow, hepatic and renal function as evidenced by:

- Liver function: bilirubin < 1.5x upper limit of normal (ULN) and SGOT (AST) <
2.5x ULN.

- Renal function: Serum creatinine <1.5 times the ULN or creatinine clearance above
50.

- Bone marrow function: WBC above 4,000/µl; platelet count above 100,000/mm3,
absolute neutrophil count above 1,500/mm3, Hemoglobin above 10 g/dl.

- Absence of brain metastases.

- No patients under the age of 21 and no pregnant or nursing women will be enrolled.
Women who are not of child bearing potential, and women of child bearing potential who
agree to use, while on study, an effective form of contraception and who have a
negative serum pregnancy test within 72 hours prior to initial study treatment. Two
forms of approved contraception measures should be used simultaneously while on trial
in premenopausal women.

- Men willing to use, while on study, an effective form of contraception.

- Ability to comply with all the aspects of the protocol and to come to the follow up
visits as per protocol.

Exclusion Criteria:

- Unacceptable uptakes to normal organs as determined after pre-enrollment PET imaging
and serum and urinary dosimetry.

- Patients with uncontrolled diabetes.

- Patients with Stage IV lymphoma that involves the bone marrow or patients with solid
tumors/ metastatic disease that involves more than 25 % of the bones.

- Patients with radioresistant tumors (i.e. melanoma).

- Patients with primary or metastatic disease to the marrow, heart or brain will be
enrolled in order to prevent potential toxicity to these organs.

- Patients with neurological disorders including strokes, seizure disorder, dizziness,
vertigo, preexisting grade 2 or higher neuropathy, tremors.

- Mini Mental Test score less than 24.

- Unexplained temperature > 101F or <95F for any 7 consecutive days or chronic diarrhea
defined as > 3 stools/day persisting for 15 consecutive days, within the 30 days prior
to treatment.

- Prior chemotherapy or surgery within one month, or prior radiotherapy within 2 months.

- Immunotherapy or biologic therapy within 1 month.

- Radiation to more than 50% of the bone marrow.

- Concurrent radiotherapy, chemotherapy. Post-menopausal women who are already using
estrogens/progestins as hormone replacement therapy are permitted to enter and to
continue using the hormones Tamoxifen and/or Aromatase Inhibitors will be accepted.

- Significant cardiac disease (i.e. uncontrolled high blood pressure, unstable angina,
congestive heart failure, myocardial infarction within the previous year) or serious
cardiac arrhythmia requiring medication.

- Active acute infection or inflammation, as determined by increased wbc and fever or
abnormal CXR. Inflammation in general can cause FDG uptake that may be severe enough
to be confused with malignant lesions, especially when there is granulomatous
inflammation such as tuberculosis, sarcoidosis, histoplasmosis, and aspergillosis
among others and patients with inflammatory disorders are excluded.

- Recent fractures within 2 months.

- Psychiatric illness/social situations that may affect the patient's compliance with
the treatment.

- Current use of illicit drugs that may affect the patient's compliance with the
treatment.