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Clinical Trial Summary

This phase I trial studies the side effects and best dose of romidepsin in treating patients with lymphoma, chronic lymphocytic leukemia, or solid tumors with liver dysfunction. Romidepsin may stop the growth of cancer cells by entering the cancer cells and by blocking the activity of proteins that are important for the cancer's growth and survival.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To establish the safety and tolerability of romidepsin given on days 1, 8, and 15 of a 28 day cycle to patients with varying degrees of liver dysfunction (mild, moderate and severe). II. To establish the maximum tolerated dose (MTD) and appropriate dosing recommendations for romidepsin in such patients. III. To characterize the pharmacokinetics (PK) of romidepsin in patients with varying degrees of liver dysfunction. SECONDARY OBJECTIVES: I. To explore correlations of the Child-Pugh classification of liver dysfunction with the observed toxicities and plasma PK of romidepsin administration. II. To document any preliminary evidence of antitumor activity at tolerable doses of romidepsin in patients with varying degrees of liver dysfunction. OUTLINE: This is a dose-escalation study. Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days. ;


Study Design


Related Conditions & MeSH terms

  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Colorectal Neoplasms
  • Glioma
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Liver Diseases
  • Lung Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Melanoma
  • Metastatic Malignant Solid Neoplasm
  • Neoplasms
  • Neuroendocrine Neoplasm
  • Neuroendocrine Tumors
  • Pancreatic Neoplasms
  • Prostatic Neoplasms
  • Recurrence
  • Recurrent Adult Soft Tissue Sarcoma
  • Recurrent Bladder Carcinoma
  • Recurrent Breast Carcinoma
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Colorectal Carcinoma
  • Recurrent Head and Neck Carcinoma
  • Recurrent Lung Carcinoma
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Melanoma
  • Recurrent Pancreatic Carcinoma
  • Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Recurrent Prostate Carcinoma
  • Recurrent Renal Cell Carcinoma
  • Recurrent Thyroid Gland Carcinoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Sarcoma
  • Skin Neoplasms
  • Stage III Breast Cancer AJCC v7
  • Stage III Colorectal Cancer AJCC v7
  • Stage III Cutaneous Melanoma AJCC v7
  • Stage III Lung Cancer AJCC v7
  • Stage III Pancreatic Cancer AJCC v6 and v7
  • Stage III Prostate Cancer AJCC v7
  • Stage III Renal Cell Cancer AJCC v7
  • Stage III Soft Tissue Sarcoma AJCC v7
  • Stage IIIA Breast Cancer AJCC v7
  • Stage IIIA Colorectal Cancer AJCC v7
  • Stage IIIA Cutaneous Melanoma AJCC v7
  • Stage IIIB Breast Cancer AJCC v7
  • Stage IIIB Colorectal Cancer AJCC v7
  • Stage IIIB Cutaneous Melanoma AJCC v7
  • Stage IIIC Breast Cancer AJCC v7
  • Stage IIIC Colorectal Cancer AJCC v7
  • Stage IIIC Cutaneous Melanoma AJCC v7
  • Stage IV Breast Cancer AJCC v6 and v7
  • Stage IV Colorectal Cancer AJCC v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Stage IV Lung Cancer AJCC v7
  • Stage IV Pancreatic Cancer AJCC v6 and v7
  • Stage IV Prostate Cancer AJCC v7
  • Stage IV Renal Cell Cancer AJCC v7
  • Stage IV Soft Tissue Sarcoma AJCC v7
  • Stage IVA Colorectal Cancer AJCC v7
  • Stage IVB Colorectal Cancer AJCC v7
  • Thyroid Neoplasms
  • Unresectable Solid Neoplasm
  • Urinary Bladder Neoplasms

NCT number NCT01638533
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 1
Start date June 12, 2012
Completion date March 5, 2025

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