Phase 1 Study OF CDC-501 in Patients With Solid Tumors

Identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment

Inclusion criteria

• Patient must understand and voluntarily sign an informed consent document.
• Age 18 years at the time of signing Informed Consent
• Histologically or cytologically documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.
• Patients must have at least one measurable or non-measurable lesion according to the RECIST Criteria (Appendix I).
• Patient has an ECOG (Zubrod) performance status of ≤ 2.
• Approximate life expectancy greater than 3 months.
• Laboratory tests within these ranges:

• Absolute neutrophil count ≥ 1,500/μlL
• Platelet count ≥100,000/μL
• Serum creatinine ≤1.5 mg/dL
• Total bilirubin ≤1.5 mg/dL
• AST (SGOT)/ALT(SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases present
• The following prior treatments are allowable under this protocol:
• Radiation, if discontinued at least 4 weeks prior to treatment under this protocol Chemotherapy, if discontinued at least 4 weeks prior to treatment under this protocol, and at least 6 weeks prior to treatment under this protocol for prior nitrosurea or mitomycin-C treatment
• Hormonal therapy for cancer, if discontinued at least 4 weeks prior to treatment under this protocol
• Other investigational drugs, if discontinued at least 4 weeks prior to treatment under this protocol
• Surgery, if minor surgery occurred at least 2 weeks prior to treatment under this protocol, or at least 4 weeks since major surgery
• Patient must be able to adhere to the study visit schedule and other protocol requirements.
• Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days prior to baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).

Exclusion criteria

• Myocardial infarction within the previous 6 months, unstable angina,symptomatic congestive heart failure, or other significant uncontrolled cardiac arrhythmia.
• Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event in the previous 6 months.
• Active infection, including known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
• CNS metastases, unless controlled by previous radiation and the patient is neurologically stable.
• Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or limit survival to less than 3 months.
• Pregnant or nursing females.Female patients of childbearing potential who are unwilling to use reliable contraceptive methods.
• Any condition, including the presence of laboratory abnormalities, which in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study.