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Investigator(s):
Anthony J.  Murgo, M.D., M.S. Principal Investigator Phone: 301-496-4291 murgoa@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 jbingham@mail.nih.gov	Sonja Crandon, R.N. Research Nurse Phone: 301-594-4325 Fax: 301-480-7281 crandons@mail.nih.gov	Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed solid tumors or lymphoma
• Metastatic or unresectable disease
• Measurable or evaluable disease
• Standard curative measures do not exist or are associated with minimal patient survival benefit
• Must have a slow acetylator NAT-2 genotype, defined as NAT-2*5, NAT-2*6, NAT-2*7, or NAT-2*14
• No known brain metastases, except for brain metastases that have remained stable for ≥ 6 months after treatment and that do not require steroids or anti-seizure medications
• Recovered from all prior therapy
• ECOG performance status 0–2 OR Karnofsky PS 60–100%
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 2.5 mg/dL in patients with Gilbert’s syndrome)
• AST and ALT ≤ 2.5 x ULN
• Creatinine < 1.5 x ULN OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing; fertile patients must use effective contraception before, during, and for 2 months after completion of study treatment
• No clinically significant illnesses including, but not limited to, any of the following:
• Active or uncontrolled infection
• Immune deficiencies
• Confirmed HIV infection
• Hepatitis B or hepatitis C
• Uncontrolled diabetes
• Uncontrolled hypertension
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Myocardial infarction within the past 6 months
• Uncontrolled cardiac arrhythmia
• Psychiatric illness or social situation that would preclude study compliance

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Treatment Plan:

This is a dose-escalation study.

• Patients receive oral batracylin on Days 1–7
• Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
• Cohorts of 1–6 patients receive escalating doses of batracylin until the maximum tolerated dose is determined
• Peripheral blood samples are collected on Days 1–4 and 7 of the first course and on Day 1 of subsequent courses for pharmacokinetic and other research studies
• After completion of study treatment, patients are followed for 4 weeks

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 8/28/08
Updated: 9/16/08