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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02130492
Recruitment Status : Suspended (The study has moved to another institution and will re-open in the near future)
First Posted : May 5, 2014
Last Update Posted : September 30, 2019
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Radiosensitive Stage IV Solid and Hematological Tumors With High FDG Uptake Not Responding to Standard of Care Lung Cancer, Head and Neck Cancer, Breast Cancer, Gastric Cancer, Pancreatic Cancer, Colon Cancer, Lymphomas, Sarcomas, Etc Radiation: FDG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Treatment of Malignant Tumors Using [18F] Fluorodeoxyglucose (FDG)
Actual Study Start Date : May 2014
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: FDG arm
Patients will receive increasing doses of FDG.
Radiation: FDG
The intervention arm consists of treatment with increasing doses of [18F]-Fluorodeoxyglucose.
Other Name: [18F]-Fluorodeoxyglucose

Primary Outcome Measures :
  1. Number of Participants with Serious and Non-Serious Adverse Events and Type of Serious and Non-Serious Adverse Events [ Time Frame: Up to 1 year post administration of FDG ]
    Evaluate for any possible side effects related to the high doses FDG administered with therapeutic intent

Secondary Outcome Measures :
  1. Efficacy Outcome Measure [ Time Frame: Up to one year post FDG treatment ]
    Tumor responses in terms of size (CT scans) or FDG uptake (FDG-PET scans) will be carefully recorded and monitored using RECIST Criteria.

Other Outcome Measures:
  1. FDG Dosimetry for Normal Organs, Tumors and/or Metastases [ Time Frame: 8 hours for each patient enrolled ]
    Evaluate dosimetry for FDG administered at high doses

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02130492

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United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10024
Sponsors and Collaborators
Weill Medical College of Cornell University
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Principal Investigator: Doru Paul, MD Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University Identifier: NCT02130492    
Other Study ID Numbers: IRB# 13-382A
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Stomach Neoplasms
Colonic Neoplasms
Breast Neoplasms
Hematologic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases
Breast Diseases
Skin Diseases
Hematologic Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action