Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer

Initially, the safety, side effects and recommended phase 2 dose of oral Karenitecin in patients with advanced solid tumors will be determined.

When the recommended phase 2 dose has been determined, the specified dose will be used to determine if Karenitecin is effective in the treatment of patients with relapsed or refractory non-small cell lung cancer.

Inclusion criteria

• Patients entering the Phase 1 portion of the study must have a histologically or cytologically documented diagnosis of cancer (solid tumors) refractory to conventional therapeutic modalities or for which no conventional treatment exists.
• Patients entering the Phase 2 portion of the study must have a histologically or cytologically documented diagnosis of advanced (Stage IIIb/IV) NSCLC.
• Patients entering the Phase 1 portion of the study can have either measurable or evaluable disease.
• Patients entering the Phase 2 portion of the study must have measurable disease meeting RECIST criteria.
• Patients must have an ECOG performance status of less than or equal to 1.
• More than 2 weeks must have elapsed since previous chemotherapy and 6 weeks from previous treatment with nitrosoureas or mitomycin-C.
• Patients must have fully recovered from the toxic effects of prior therapy.
• Patients entering the Phase 1 portion of the study may have received up to two prior chemotherapy programs including adjuvant or neoadjuvant therapy.
• Patients entering the Phase 2 portion of the study may have received only one prior chemotherapy program including adjuvant or neoadjuvant therapy for NSCLC.
• More than 2 weeks must have elapsed since previous radiation therapy and prior radiation must be less than or equal to 15% of the bone marrow.
• Required Initial Laboratory Data: *ANC ≥ 1,500/mm3, *Platelet count ≥ 100,000/mm3, *SGPT < 1.5 times ULN, *Alkaline phosphatase < 2.0 times ULN, *Bilirubin < 1.5 mg/dl, *Serum creatinine < 1.5 times ULN

Exclusion criteria

• Pregnant or lactating women.
• Uncontrolled high blood pressure, uncontrolled diabetes mellitus, unstable angina, symptomatic congestive heart failure (CHF), myocardial infarction (MI) within 6 months, or uncontrolled arrhythmia.
• Phase 2 no previous or concurrent malignancy
• Central Nervous System (CNS) metastasis if neurologically unstable or requiring steroid use.
• Active infection.
• Known positive HIV status.
• Conditions requiring use of H2 blockers or other antacids.
• Inability to provide informed consent.