A Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed
• •Locally advanced or metastatic non-hematologic malignancies
• •Measureable
• •Refractory to standard therapies or single agent gemcitabine is indicated as a standard treatment option
• •PRIOR/CONCURRENT THERAPY:
• •No concurrent radiotherapy, chemotherapy, immunotherapy or other investigational agents
• •Must have recovered from side effects of prior therapies
• •PATIENT CHARACTERISTICS:
• •Life expectancy
• •\> 12 weeks
• •Performance Status
• •ECOG 0 or 1
• •Bone Marrow Reserve
• •Absolute Neutrophil count (AGC/ANC) ≥ 1,500/uL
• •Platelets ≥ 100,000/uL
• •Hemoglobin \> 9 g/dL
• •Renal Function
• •Calculated Glomerular filtration rate (GFR) \> 59mL/min/1.73M\^2
• •Hepatic Function
• •Total bilirubin ≤ 1.5 X ULN
• •AST, ALT, and ALP ≤ 3 X ULN or ≤ 5.0 x ULN, if liver metastasis exists
• •PT INR ≤ 1.5 X ULN
• •Cardiovascular
• •No history of clinically significant vascular disease
• •No New York Heart Association (NYHA) Class \> II heart failure
• •Hematologic
• •No history of bleeding disorders
• •No evidence of bleeding diathesis or coagulopathy
• •No presence of clinically significant hemoptysis or hematuria, presence of serious non-healing wound or ulceration, or signs of other bleeding
• •No evidence of a tumor invasion of any major blood vessel
• •No trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within two months of study entry
• •Surgery/Procedures
• •No major surgery or open biopsy within 28 days before drug infusion or evidence of active bleeding postoperatively
• •No plan for any major surgery during treatment period
• •No presence or requirement of an epidural catheter or lumbar puncture within 48 hours prior to each dose of study treatment
• •No anticipation of receiving an epidural catheter or a lumbar puncture within 48 hours after each dose of study treatment
• •Excluded Medications or Treatment Regimens
• •Unfractionated heparin of \> 15,000 units/day within 8 hours prior to each dose of study treatment
• •Low-molecular weight heparin at a higher dose than recommended for prophylactic used or required within 20 hours prior to each dose of study treatment
• •Warfarin used or required within 48 hours prior to each dose of study treatment and the prothrombin time (INR) exceeded the upper limit of normal range
• •Direct thrombin inhibitors or Xa inhibitors
• •Acetylsalicylic acid used or required within 72 hours prior to each dose of study treatment
• •Clopidogrel bisulfate used or required within 48 hours prior to each dose of study treatment
• •Anticipated requirement for anti-platelet or anti-coagulant agents excluding non-aspirin NSAID within 48 hours following study treatment infusion
• •Other
• •No active systemic infection requiring parenteral antibiotic therapy
• •No history of or presence of a CNS disease
• •No history of allergic reactions to compounds of similar chemical or biologic composition
• •Not HIV positive
• •No women who are pregnant or nursing
• •A negative serum pregnancy test if female
• •Patients, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
• •No history of significant renal, endocrinologic, metabolic, immunologic or hepatic disease
• •No evidence of psychiatric illness/social situations
• •Other illness that in the opinion of the investigator would exclude the patient from participating
• •Must provide informed consent and HIPAA authorization and comply with protocol-specified procedures and follow-up evaluations