Clinical trial NCT00633087 (phase 1/phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: 2-deoxyglucose
SMILES: [H]C([H])(C=O)[C@@]([H])(O)[C@]([H])(O)[C@]([H])(O)CO
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  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             withdrawn, must demonstrate progression of disease and be at least 6 weeks and 4 weeks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.

          -  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.

        Exclusion Criteria:

          -  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.

          -  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.