AT13387 in Adults With Refractory Solid Tumors

Inclusion Criteria

• •Patients must have histologically documented (confirmed at the Laboratory of Pathology, NCI) solid tumor malignancy that is metastatic or unresectable, for which standard curative measures do not exist, or have failed at least one line of standard therapy.
• •Patients must have measurable or evaluable disease.
• •Patients must have completed any chemotherapy, radiation therapy, or biologic therapy greater than or equal to 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C).
• •Patients must be greater than or equal to 2 weeks since any prior administration of a study drug in an exploratory IND/Phase 0 study. Patients must have recovered to eligibility levels from prior toxicity or adverse events. Patients receiving bisphosphonates for any cancer are eligible to participate.
• •Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of AT13387 in patients \< 18 years of age, children are excluded from this study.
• •The Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
• •Life expectancy \> 3 months.
• •Patients must have normal or adequate organ and marrow function as defined below:
• •* Absolute neutrophil count greater than or equal to 1,500/microL
• •* Platelets greater than or equal to 100,000/microL
• •* Total bilirubin less than or equal to 1.5 times institutional ULN
• •* AST (SGOT)/ALT (SGPT) less than or equal to 2.5 times institutional ULN
• •* Creatinine \<1.5 times ULN; OR
• •* Measured creatinine greater than or equal to 60 mL/minute for patients with clearance creatinine levels greater than or equal to 1.5 times ULN
• •The effects of AT13387 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for 2 months after completion of study. Women of childbearing potential must have a negative pregnancy test within 72 hours of enrollment in order to be eligible. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk to nursing infants secondary to treatment of the mother with AT13387, breastfeeding should be discontinued if the mother is treated with AT13387.
• •During the expansion phase of the protocol, patients must have:
• •* Disease amenable to biopsy
• •* Willingness to undergo pre- and post-treatment biopsies
• •Ability to understand and the willingness to sign a written informed consent document.
• •Currently enrolling in the expansion phase. Patients must have:
• •Disease amenable to biopsy
• •Willingness to undergo pre- and post-treatment biopsies