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Investigator(s):
Shivaani Kummar, M.D. Principal Investigator Phone: 301-435-5402 kummars@mail.nih.gov	Giovanni Melillo, M.D. Protocol Chair Phone: 301-846-5050 melillog@ncifcrf.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 jbingham@mail.nih.gov	Mary Ann Yancey, R.N. Research Nurse Phone: 301-435-9227 yanceym@mail.nih.gov

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Primary Eligibility:

• Age 18 or over
• Histologically confirmed solid tumor that is metastatic or unresectable and which has either progressed following standard therapy or for which there is no recommended standard treatment
• Tumor that can be biopsied with a minimal-to-small amount of risk and expresses HIF-1 alpha protein as measured by immunohistochemistry
• AST and ALT ≤ 2.5 times upper limit of normal (ULN); Bilirubin ≤ 1.5 times ULN; Creatinine ≤ 1.5 mg/dL
• No prior therapy with topotecan
• No known brain metastases
• No active peptic ulcer or GI condition that could alter absorption or motility
• Not HIV positive

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Treatment Plan:

• Patients receive oral topotecan daily for 2 consecutive weeks (5 consecutive days followed by a 2-day rest period)
• Treatment will be repeated every 28 days
• Imaging studies will be performed at baseline, at the end of treatment on cycle 1 (day 9 or 10), at the end of treatment on cycle 2 (day 12 or 13), and then every two cycles

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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.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 8/28/08
Updated: 11/14/08