Solid Tumor
A Phase I and Pharmacokinetic Single-agent Study of Romidepsin in Patients With Lymphomas, Chronic Lymphocytic Leukemia, Select Solid Tumors, and Varying Degrees of Liver Dysfunction
NCI-12-C-0177, NCT01638533
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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
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Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov
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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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Lemual Clayborn Referral Coordinator Phone: 301-451-0992 Fax: 301-496-0826 claybornlr@mail.nih.gov
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Key Eligibility Criteria:
- Diagnosis of lymphoma, chronic lymphocytic lymphoma (CLL), or solid tumor*
- Patients with lymphoma or CLL must be refractory to standard therapy
- Patients with solid tumors must have radiologically evaluable disease that is metastatic, unresectable, progressive, or recurrent and for which standard curative measures do not exist or are no longer effective
- ECOG ≤ 2
- Adequate renal and bone marrow function
- Patients with abnormal liver function are eligible
- No evidence of significant cardiovascular disease
- No uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
* Excluding prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma, and thyroid cancer because of a lack of efficacy in these tumor types in phase 2 studies
Study Outline:
- Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
- Patients receive romidepsin intravenously (IV) (through a vein) over 4 hours on days 1, 8, and 15 of a 28-day cycle
- Cycles repeat every 28 days 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
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: 10/1/12