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Prostate CancerPhase 1/22-DeoxyglucoseNCT00633087

A Phase I/II Trial of 2-Deoxyglucose (2DG) for the Treatment of Advanced Cancer and Hormone Refractory Prostate Cancer

A Phase 1/2 study testing 2-deoxyglucose in people with Prostate Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Subjects will be asked to participate in this clinical trial to examine the safety of 2-deoxyglucose (an agent which is quite similar to glucose) in the treatment of solid tumors and hormone refractory prostate cancer. This agent works by blocking the metabolism of glucose in the cells of the body. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer
What is being tested?
2-deoxyglucose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Nov 2006to Mar 2011
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with any histologically proven metastatic solid tumor malignancy, without a standard option of therapy will be eligible for the Phase I portion of this trial. Patients with prostate cancer with metastatic disease, and progression after initial hormonal therapy will be eligible for both the Phase I and II portion of this trial. Phase II patients must have either measurable disease or a PSA value > 5 ng/ml.
  • Patients with prostate cancer in whom bicalutamide or flutamide has been recently withdrawn, must demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively beyond the discontinuation of such agents. LHRH agonists will be continued.
  • Age >18 years and an estimated life expectancy of at least 6 months.
  • ECOG performance status < 2. (see Appendix B)
  • Patients must be ³ 4 weeks since last prior therapy (including surgery, chemotherapy, radiation therapy). All previous clinically significant treatment-related toxicities have resolved to less than or equal to Grade 1.
  • An ANC >1500/µl, hemoglobin > 10 g/dl, and platelet count >100,000/µl are required.
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  • Adequate renal function (serum creatinine < 1.5 mg/dL or creatinine clearance > 50 ml/min)
  • Total bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) must be less than 2.5X the institutional upper limit of normal.
  • Serum potassium within institutional limit of normal.
  • Fasting blood glucose < institutional ULN.
  • In the Phase I portion of this study patients may have had prior chemotherapy.
  • In the Phase II portion of this study patients may not have had prior chemotherapy.
  • Women of childbearing potential must have a negative pregnancy test (Phase I trial).
  • Men and women of childbearing potential must consent to using effective contraception while on treatment and for 3 months thereafter.

Who cannot join

  • Known infection with HIV. Patients without prior HIV testing will not be required to be tested.
  • History of glucose intolerance.
  • Patients with ongoing coagulopathies and/or receiving oral anticoagulants.
  • Second primary malignancy except most situ carcinoma (e.g. in situ carcinoma of the of the cervix, adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least 5 years previously with no evidence of recurrence.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Patients with diabetes mellitus, hypoglycemia, history of seizure disorder, known autonomic dysfunction, clinically significant uncontrolled gastrointestinal disorder, known G6PD deficiency, and allergy to methylparaben or propylparaben will be excluded, based on known potential toxicities.
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  • The effects of 2-deoxyglucose on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because Agent Class as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 3 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Active clinically significant infection requiring antibiotics.
  • History of clinically significant unexplained episodes of hypotension, fainting, dizziness, or lightheadedness.5.2.10 History or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4; see Appendix D, New York Heart Association Criteria) within the last 6 months, particularly coronary artery disease, arrhythmias, or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure.
  • History of transient ischemic attack, stroke, or seizure disorder or any other CNS disease considered to be significant by the investigator.
  • Major surgery within 4 weeks of the start of study treatment, without complete recovery.
  • Antitumor therapy within 28 days of the start of study treatment (within 6 or 4 weeks for bicalutamide or flutamide, respectively).
  • Phase I only: Inability to discontinue prohibited medications for 24 hours before and after dosing on Cycle 1, Day 1 of Weeks 1 and 2.
  • Patients who are unable (as per Investigator discretion) or unwilling to give written informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Subjects will be asked to participate in this clinical trial to examine the safety of 2-deoxyglucose (an agent which is quite similar to glucose) in the treatment of solid tumors and hormone refractory prostate cancer. This agent works by blocking the metabolism of glucose in the cells of the body. Although all cells require glucose for metabolism, it is believed that cancer cells require significantly more glucose than normal cells to grow. Therefore, even slight effects of glucose metabolism in cancer cells might result in the shrinkage of certain cancers. This agent has been given to humans before and has only caused mild nausea, vomiting and glucopenia (low blood sugar) at the doses given in these studies. This study will further examine the safety of 2-deoxyglucose in the treatment of advanced solid tumors and hormone refractory prostate cancer. The information obtained in this study will be used to design future clinical studies with 2-deoxyglucose. Subjects will be asked to take an oral solution of 2-deoxyglucose daily, by mouth, while on this study. They will be asked to have CT Scans, Bone Scans, and optional PET (Positron Emission Tomography) Scans prior to starting this study. PET scans will also be performed shortly after the start of the study and after 2 cycles (6 weeks) of therapy. Subjects will be asked to have a comprehensive physical examination and blood work prior to the start of the study. During the first 2 cycles of the study subjects will be asked to have blood drawn at different time intervals for the first 2 days of each cycle. While on the study, they will be asked to return to the clinic at intervals of 1 week for a physical examination and blood tests. Subjects will also be asked to have CT Scans and Bone Scans at intervals of 9 weeks while on the study.

Conditions
Prostate Cancer
Being tested
2-deoxyglucose
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2-deoxyglucoseDrug

    Also called Two-deoxyglucose

    30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.

Study groups in NCT00633087
Study groupRoleWhat they receive
2-deoxyglucoseExperimentalNot described
Receives: Drug: 2-deoxyglucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To Determine the Biochemical Response of This Regimen in Patients With HRPC

    A PSA response is defined as a PSA decrease of 50% from baseline maintained for at least 28 days.

    Measured: 5 years

Secondary outcomes (3)

  1. Duration of Response

    Measured: 5 years

  2. Progression-free Survival

    Measured: 5 years

  3. Overall Survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2008 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2011
  4. Study completionMar 2011

Why it stopped: Slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00633087
Sponsor's protocol ID
080402
Other IDs
IRB# 0220044763
Acronym
2-Deoxyglucose
Status last verified
Dec 2023
First submitted
3 Mar 2008
Last updated
22 Dec 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 2-deoxyglucose in people with Prostate Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Determine the Biochemical Response of This Regimen in Patients With HRPC (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00633087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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