A Phase I Study and Pharmacological Trial of Once Weekly Aminoflavone Prodrug (AFP464) Administered 3 Out of Every 4 Weeks in Solid Tumor Patients

Date de début de l'étude : 1 juillet 2006

Inclusion Criteria: * Histologic proof of cancer that is now unresectable * Patients with metastatic solid tumors who are refractory to available therapy or for whom standard systemic therapy does not exist * Absolute neutrophil count (ANC) \>= 1500/μL * Platelets (PLT) \>= 100,000/μL * Total bilirubin =\< upper limits of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN * Creatinine =\< 1.25 x ULN; if above 1.25 x ULN calculated creatinine clearance must be \>= 60 ml/min * Hemoglobin (Hgb) \>= 9.0 g/dl * Normal diffusing capacity of the lung for carbon monoxide (DLCO) or the presence of an asymptomatic grade 1 DLCO; NOTE: DLCO must be corrected for hemoglobin * Ability to provide informed consent * Willingness to return to Mayo Clinic for follow-up * Life expectancy \>= 12 weeks * Willingness to provide the biologic specimens (blood and urine) as required by the protocol * COHORT II (MTD) PATIENTS ONLY: * Patients with breast, ovarian, peritoneal or renal cell carcinoma * Tumor that is amenable for biopsy taken during Cycle 1 at 24 +/- 4 hours following the end of AFP-464 infusion * International normalized ratio (INR) =\< 1.4 * Patients taking aspirin: discontinue \>= 5 days prior to procedure * Patients receiving IV Heparin: discontinue 4 hours prior to the procedure and an APTT measurement obtained if clinically indicated * Patients receiving subcutaneous or low molecular weight heparin: discontinue for 8 hours prior to procedure Exclusion Criteria: * Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 3 or 4 * Prior thoracic radiotherapy * Symptomatic pulmonary disease * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements * Any of the following prior therapies: * Chemotherapy =\< 4 weeks prior to study entry * Mitomycin C/nitrosoureas =\< 6 weeks prior to study entry * Immunotherapy =\< 4 weeks prior to study entry * Biologic therapy =\< 4 weeks prior to study entry * Radiation therapy =\< 4 weeks prior to study entry * Radiation to \> 25% of bone marrow * Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment * Uncontrolled brain metastases; Note: Brain metastases are not permitted on study unless the metastases have been treated by surgery or radiotherapy, and the patient has been neurologically stable and off steroids for \>= 4 weeks * Any of the following: * Pregnant women: Females of childbearing potential must have a negative serum pregnancy test =\< 7 days prior to registration * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * History of allergic reactions attributed to compounds of similar chemical or biologic composition to AFP464 * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation) * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy * Active smokers and those who have smoked =\< 30 days prior to registration, and patients unwilling or unable to refrain completely from smoking while on study