Clinical Trial · NCT02130492

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

Overview

The objectives of this Pilot study are to investigate the toxicity and safety of high doses of \[18F\]-Fluorodeoxyglucose (FDG) used as a therapeutic agent in patients with advanced stage IV malignant tumors that failed standard of care treatment, have a good performance status and bear radiosensitive tumors with a high \[18F\]-FDG uptake. The investigators hypothesize that \[18F\]FDG may have a significant tumoricidal effect on cancer cells and radionuclide therapy of cancers with high doses of \[18F\]FDG administered as a single dose or in multiple doses (dose fractionation regimen) can be safe and well tolerated with minimal toxicities. Advantages of FDG are its uptake in many different human tumors, its short half-life (110 minutes) and the possibility to monitor its effect closely with the FDG-PET scan. The rationale for using high doses of this radiopharmaceutical agent for treatement is that most malignant lesions have accentuated glucose metabolism, which is mirrored by increased uptake of FDG. Since FDG cannot be metabolized within the cell like glucose, it is effectively confined within the cancer cells; thus, FDG treatment is potentially a novel form of targeted therapy for tumors with increased FDG uptake.

Sponsor

Weill Medical College of Cornell University

Phase

Phase 1/2

Contacts

Doru Paul, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02130492

Drug / Compound

FDG

Isotope(s):

Target(s):

Glucose Transport

Ligand Class: Small Molecules

Eligibility

Inclusion

ECOG performance status equal to or less than 2.
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.
Renal function: Serum creatinine \<1.5 times the ULN or creatinine clearance above 50.
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:
Stage IV solid cancers and stage IV lymphomas that failed to respond to two or more regimens of standard chemotherapy.

Exclusion

Radiation to more than 50% of the bone marrow.
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.
Immunotherapy or biologic therapy within 1 month.
Prior chemotherapy or surgery within one month, or prior radiotherapy within 2 months.
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 uncontrolled diabetes.
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.
Mini Mental Test score less than 24.
Unacceptable uptakes to normal organs as determined after pre-enrollment PET imaging and serum and urinary dosimetry.
Patients with primary or metastatic disease to the marrow, heart or brain will be enrolled in order to prevent potential toxicity to these organs.
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.
Patients with radioresistant tumors (i.e. melanoma).