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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

Referral Contact(s):

Janelle Bingham, R.N.
Referral Coordinator
Phone: 301-435-2715
Fax: 301-451-5433
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

Lemual Clayborn
Referral Coordinator
Phone: 301-451-0992
Fax: 301-496-0826
claybornlr@mail.nih.gov

 

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

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