Safety Study of a Cell Penetrating Peptide (p28) to Treat Solid Tumors That Resist Standard Methods of Treatment

Inclusion Criteria:

* Patients must have histologically proven solid tumor disease with documentation of measurable metastatic disease as defined by RECIST.
* The term refractory solid tumor signifies patients with metastatic solid tumors who have failed all standard therapy or for whom no standard therapy exists.
* In patients with refractory solid tumors, a pretreatment biopsy (either of the original primary or metastatic deposit) must show p53 (wild-type and to an extent mutant) expression by means of immunocytochemistry.
* Patients must have distant metastases or unresectable local disease, but a projected life expectancy of at least 6 months.
* Patients must have signed an informed consent.
* This study is confined to adults of both sexes, age 18 or older.
* Patients must have no medical problems that would pose an undue risk or that would limit full compliance with the study.
* A minimum of 4 weeks must have elapsed since the completion of prior therapy, including hormonal therapy, chemotherapy, radiation therapy, immunotherapy, oral tyrosine kinase inhibitors and monoclonal antibodies.
* Adequate baseline organ function assessed by the following laboratory values within 30 days prior to study entry:

  * Granulocyte count \>1,500/mm3, hematocrit \>30%, and platelets \>100,000/mm3.
  * Calculated creatinine clearance \>50ml/min.
  * Adequate liver function with SGOT, SGPT, LDH, and alkaline phosphatase \<3 x the upper limit of normal; serum bilirubin \<2.0 mg/dl.
  * PT and PTT not more than 1.5 times the upper limit of normal.
* Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTs will be evaluated by a cardiologist or pulmonary physician prior to enrollment of this protocol.

Exclusion Criteria:

* Patients who are undergoing chemotherapy or immunotherapy, i.e., cytokines
* Patients with refractory solid tumors whose primary tumor or metastatic deposits do not express p53 (null) will not be eligible.
* Patients with serious additional illness, including HIV, hepatitis, or untreated active infection.
* Patients with any underlying conditions that would contraindicate therapy with the study agent.
* Patients with a history of prior malignancy in the past five years other than the current problem for which he/she is being considered for this trial (patients with prior history of basal cell carcinoma or squamous cell skin cancer are eligible).
* Patients with any other serious medical, i.e., cardiovascular, uncontrolled diabetes (insulin resistant), or psychiatric illness that would prevent informed consent will not be eligible to participate in the study.
* Patients who are either pregnant or lactating (all patients of childbearing potential will receive a pregnancy test within 2 days of study initiation).
* Brain Metastases, current or past (unless treated at least one year prior to enrollment).