- Karnofsky Performance Status (KPS) > 70%.
- Histologically-confirmed advanced malignancy for which a standard, approved therapy
is not available.
- Adequate renal, liver, pancreatic and hematologic function
- Signed informed consent (sample IC form is provided in Appendix A).
- Administration of chemotherapy, biological, immunotherapy or investigational agent
(therapeutic or diagnostic) within 28 days
- Patients that require G-CSF and/or platelet support during screening and are likely
to require G-CSF and/or platelet support for the duration of the clinical trial.
- Patients with ongoing coagulopathies and/or taking anticoagulants
- Patients receiving intrathecal therapy.
- Known brain metastases.
- Pre-existing adrenal insufficiency; concomitant therapy with replacement
corticosteroids. Pre-existing acute or chronic pancreatitis.
- Significant cardiac disease.
- Pregnant or breast-feeding women.
- Concurrent, active secondary malignancy for which the patient is receiving therapy.
(Lymphoma patients with a diagnosis of a potentially hormone-sensitive tumor who are
without evidence of disease for this second malignancy may continue to receive
- Patients with proteinuria Grade 2 or greater
- Active uncontrolled bacterial or fungal infection requiring systemic therapy;
infection requiring parenteral antibiotics.
- Patients who are known to be HIV positive or have active Hepatitis A, B, or C