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

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