Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 132
Summary
- Conditions
- Glioma
- Hematopoietic and Lymphoid Cell Neoplasm
- Stage III Cutaneous Melanoma AJCC v7
- Stage III Renal Cell Cancer AJCC v7
- Stage IV Breast Cancer AJCC v6 and v7
- Stage III Colorectal Cancer AJCC v7
- Stage IIIC Colorectal Cancer AJCC v7
- Stage IV Lung Cancer AJCC v7
- Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Stage IIIA Cutaneous Melanoma AJCC v7
- Stage III Breast Cancer AJCC v7
- Lymphoma
- Stage IIIA Breast Cancer AJCC v7
- Metastatic Malignant Solid Neoplasm
- Neuroendocrine Neoplasm
- Recurrent Adult Soft Tissue Sarcoma
- Stage IIIB Colorectal Cancer AJCC v7
- Stage IV Prostate Cancer AJCC v7
- Unresectable Solid Neoplasm
- Stage IIIA Colorectal Cancer AJCC v7
- Stage IV Pancreatic Cancer AJCC v6 and v7
- Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
- Stage IV Renal Cell Cancer AJCC v7
- Stage III Soft Tissue Sarcoma AJCC v7
- Recurrent Bladder Carcinoma
- Stage IIIB Cutaneous Melanoma AJCC v7
- Stage IVB Colorectal Cancer AJCC v7
- Recurrent Lung Carcinoma
- Recurrent Renal Cell Carcinoma
- Recurrent Prostate Carcinoma
- Recurrent Breast Carcinoma
- Recurrent Chronic Lymphocytic Leukemia
- Refractory Chronic Lymphocytic Leukemia
- Stage IIIC Breast Cancer AJCC v7
- Stage IVA Colorectal Cancer AJCC v7
- Recurrent Thyroid Gland Carcinoma
- Stage IIIB Breast Cancer AJCC v7
- Recurrent Pancreatic Carcinoma
- Recurrent Colorectal Carcinoma
- Recurrent Melanoma
- Stage IV Cutaneous Melanoma AJCC v6 and v7
- Stage III Lung Cancer AJCC v7
- Stage III Prostate Cancer AJCC v7
- Stage IV Soft Tissue Sarcoma AJCC v7
- Stage III Pancreatic Cancer AJCC v6 and v7
- Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
- Recurrent Head and Neck Carcinoma
- Recurrent Malignant Solid Neoplasm
- Stage IIIC Cutaneous Melanoma AJCC v7
- Stage IV Colorectal Cancer AJCC v7
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 r...
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.
Tracking Information
- NCT #
- NCT01638533
- Collaborators
- Celgene Corporation
- Investigators
- Principal Investigator: Roisin M Connolly JHU Sidney Kimmel Comprehensive Cancer Center LAO
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