Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction

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.

Conditions

• Glioma
• Hematopoietic and Lymphoid Cell Neoplasm
• Lymphoma
• Metastatic Malignant Solid Neoplasm
• Neuroendocrine Neoplasm
• 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
• 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
• Unresectable Solid Neoplasm

Interventions

OTHER

Pharmacological Study

Correlative studies

DRUG

Romidepsin

Given IV

Sponsors & Collaborators

• Celgene Corporation

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Roisin M Connolly · JHU Sidney Kimmel Comprehensive Cancer Center LAO

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-03

Primary Completion

2018-11-29

Completion

2020-09-01

Countries

• United States
• Canada

Study Locations