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Investigator(s):
Shivaani Kummar, M.D. Principal Investigator Phone: 301-435-5402 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 jbingham@mail.nih.gov	Deborah Allen, R.N., O.C.N. Research Nurse Phone: 301-402-5640 Fax: 301-480-7281 allendeb@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed solid tumors and lymphoid malignancies (i.e., lymphoma or chronic lymphocytic leukemia) refractory to standard therapy OR with no acceptable standard treatment options
• No known brain metastases
• Prior ABT-888 and topotecan hydrochloride (TPT) allowed
• ≥ 18 years of age
• ECOG 0–2
• ANC ≥ 1,500/µL
• Platelet count ≥ 100,000/µL
• Total bilirubin < 1.5 x upper limit of normal (ULN)
• AST and ALT ≤ 2.5 x ULN
• Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min
• Prior therapy must have been completed ≥ 4 weeks prior to enrollment
• Not pregnant or nursing; must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study
• No uncontrolled intercurrent illness that would limit compliance with study requirements
• No history of seizures

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Treatment Plan:

Course 1:

• Patients receive topotecan hydrochloride (TPT) intravenously on Days 1–5 and oral ABT-888 twice daily on Days 2-5
• Two weeks later, patients proceed to course 2
• Peripheral blood monocyte samples for pharmacodynamic analysis are obtained on Days 1 and 2 over a period of 24 hours each
• Blood sampling is performed at multiple time points over a 24-hour period on Days 1 and 2
• Tumor biopsies are obtained on Day 1

Course 2 and beyond:

• Patients receive oral ABT-888 twice daily on Days 1–5 and TPT IV on Days 1–5
• Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression
• Peripheral blood monocyte samples for pharmacodynamic analysis are obtained on Days 1 and 2 over a period of 24 hours each for Cycle 2

• After completion of study therapy, patients are followed for 30 days

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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: 8/29/08
Updated: 10/14/08