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

NCT02130492 | Suspended Phase 1 DMC

• 1 other identifier: IRB# 13-382A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

Stage IV cancers; Advanced lymphomas; Advanced sarcomas; Advanced solid tumors; Advanced cancers; Recurrent cancers; Hypermetabolic tumors

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 1 year post administration of FDG

Secondary Outcomes (1)

• Efficacy Outcome Measure

  Up to one year post FDG treatment

Other Outcomes (1)

• FDG Dosimetry for Normal Organs, Tumors and/or Metastases

  8 hours for each patient enrolled

Study Arms (1)

FDG arm

EXPERIMENTAL

Patients will receive increasing doses of FDG.

Radiation: FDG

Interventions

FDG RADIATION

The intervention arm consists of treatment with increasing doses of \[18F\]-Fluorodeoxyglucose.

Also known as: [18F]-Fluorodeoxyglucose

FDG arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10024, United States

Location

Related Publications (1)

• Paul DM, Ghiuzeli CM, Rini J, Palestro CJ, Fung EK, Ghali M, Ben-Levi E, Prideaux A, Vallabhajosula S, Popa EC. A pilot study treatment of malignant tumors using low-dose 18F-fluorodeoxyglucose (18F-FDG). Am J Nucl Med Mol Imaging. 2020 Dec 15;10(6):334-341. eCollection 2020.

  PMID: 33329935 RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Doru Paul, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 5, 2014
• Study Start: May 1, 2014
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 23, 2025

Record last verified: 2025-10

Locations

US (1)