A Phase I Study of Systemic Gene Therapy With SGT-94 in Patients With Solid Tumors

Inclusion Criteria:

* Histologic proof of cancer for which no standard therapy is available, and which shows no staining for RB by IHC.
* Spirometry with at least 70% of predicted volumes (including FEV1). A left ventricular ejection fraction (LVEF) of 45% or more. All patients will have a screening 2-D Echocardiogram as part of eligibility screening.
* Patients must have adequate physiologic reserve as evidenced by:

  * Zubrod Performance Status (PS) of \</= 2; or 3 if of recent onset (i.e. \< 2 weeks) and if the compromised performance status is related to uncontrolled pain which is expected to come under control by means of improved pain management.
  * Laboratory values meeting the following criteria:

    * Absolute neutrophil count \>/= 1,200/mm3
    * Platelet count \>100,000/mm3.
    * AST and ALT \</= 3x the upper limit of normal
    * Conjugated bilirubin \</= 1.5 mg/dL (or total bilirubin \</= 2.5 mg/dL)
    * Native kidney function producing creatinine clearance (either measured or estimated by Cockcroft formula) of at least 40 mL/min. Cockcroft formula: CLcr = \[(140-age) • wt(kg)\]/\[72 •Creat (mg/dL)\] (For females, multiply by 0.85)
    * Hemoglobin \>/= 10.0 g/dL without transfusion support
    * White blood cell count \> 3.0 k/mm3
    * PT and aPTT each \< 1.5 times the upper limit of normal.
* Women of child-bearing potential must have a negative pregnancy test.
* Male and female patients reproductive potential must agree to use measures to avoid pregnancy throughout the study and for 3 months following discontinuing study drug.
* Patients must have recovered from any previous therapy side effects or toxicities prior to initiating protocol study infusions.
* Life expectancy \> 12 weeks.
* Organ function \</= grade 1.
* Age of \</= 18 years.

Exclusion Criteria:

* Some prior cancer therapies are not consistent with eligibility; specifically:

  * At least 30 days must have elapsed since any prior experimental therapy
  * At least 6 weeks must have elapsed since prior systemic mitomycin C
  * At least 8 weeks must have elapsed since any dose of Strontium-89
  * At least 4 weeks must have elapsed since prior Sm-153 lexidronam (Quadramet™)
  * At least 4 weeks must have elapsed since prior radiotherapy
  * Any prior exposure to gene vector delivery products
* Pregnancy or lactation
* Serious concurrent medical illness that in the opinion of the investigator would compromise patient safety or preclude accurate assessment of outcome.
* Patients with the following manifestations of cardiovascular disease are excluded:

  * Myocardial infarction (MI) within the previous six months, or patients with left ventricular ejection fraction of less than 45% secondary to a more remote MI.
  * Any history of CVA or TIA in previous six months
  * New York Heart Association grade 2 or greater congestive failure
  * Unstable angina defined as angina (or anginal equivalent) 2 or more times per week despite medical therapy.
  * Echocardiographic evidence of pulmonary hypertension.
  * Diastolic dysfunction felt to contribute to any clinical sign or symptom.
  * Uncontrolled hypertension, defined as systolic BP \>140 or diastolic \>90 despite therapy.
* Serious concurrent psychiatric disorder that in the opinion of the investigator would compromise patient safety or preclude accurate assessment of outcome.
* Supraphysiologic doses of glucocorticoids (defined as \> 30 mg of hydrocortisone per day or \> 7.5 mg of Prednisone per day, or equivalent doses of other agents) or exposure to other immunosuppressive medications in the previous 30 days.
* Requirement for anticoagulant therapy other than low intensity treatment to maintain patency of central venous catheters.
* Treatment with antibiotics for proven infection within 1 week prior to study entry or signs and symptoms consistent with an active infection or fever \> 38.1 C.