Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"

Inclusion Criteria

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.