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.
Photons, electrons and protons have therapeutic use however positrons have only been used for diagnostic imaging purposes.. The energies of positrons (β+) from F-18 (0.633 MeV) and electrons (β-) from I-131 (0.606 MeV) are very close and have similar equilibrium dose constants. Since \[18F\]- fluorodeoxyglucose (18F-FDG) clears rapidly from circulation, administration of 37-74 BGq (1-2 Ci) of 18F-FDG is relatively safe from an internal radiation dosimetry point of view. We initiated a phase I dose escalation study to assess the safety, toxicity, and potential therapeutic utility of administering high doses of 18F-FDG delivered over a 1 to 5 day period in patients with advanced lymphomas and solid tumors refractory to standard of care treatment (SCT). There will also be a Phase 2 portion of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The intervention arm consists of treatment with increasing doses of \[18F\]-Fluorodeoxyglucose.
Weill Medical College of Cornell University
New York, New York, United States
Number of Participants with Serious and Non-Serious Adverse Events and Type of Serious and Non-Serious Adverse Events
Evaluate for any possible side effects related to the high doses FDG administered with therapeutic intent
Time frame: Up to 1 year post administration of FDG
Efficacy Outcome Measure
Tumor responses in terms of size (CT scans) or FDG uptake (FDG-PET scans) will be carefully recorded and monitored using RECIST Criteria.
Time frame: Up to one year post FDG treatment
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