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Investigator(s):
Shivaani Kummar, M.D., F.A.C.P. Principal Investigator Phone: 301-435-0517 Fax: 301-496-0826 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov	Lemual Clayborn Referral Coordinator Phone: 301-451-0992 Fax: 301-496-0826 claybornlr@mail.nih.gov	Ramya Parthasarathy, B.S.N., R.N., O.C.N. Research Nurse Phone: 301-594-4949 Fax: 301-480-7281 parthasarathyr@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed diagnosis of a solid tumor or low-grade non-Hodgkin lymphoma
• Failed at least one line of prior therapy or have a disease for which no standard curative therapy exists
• Measurable or evaluable disease
• ECOG ≤ 2
• Adequate organ and bone marrow function
• Absolute neutrophil count ≥ 1,500/microL
• Platelets ≥ 100,000/microL
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN)
• No uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
• Participants enrolling in the expansion phase must have disease amenable to biopsy and willing to undergo pre- and post-treatment biopsies
• No therapy within 4 weeks of entering the study

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Study Outline:

• Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
• Patients will receive a fixed dose of PU-H71 intravenously (through a vein) once weekly, 2 weeks out of 3 (i.e., on Days 1 and 8) every 21 days (one cycle)
• Cycles continue for as long as there is no progressive disease or unacceptable toxicity
• Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment

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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: 9/12/12
Updated: 9/20/12