The purpose of this study is to determine the maximum safe dose of orally administered
Karenitecin (BNP1350) in patients with solid tumors.
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.
- 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
- 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
- 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
- Active infection.
- Known positive HIV status.
- Conditions requiring use of H2 blockers or other antacids.
- Inability to provide informed consent.