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Phase I Study of Romidepsin Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT01590732
Recruitment Status : Active, not recruiting
First Posted : May 3, 2012
Last Update Posted : October 2, 2017
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is find the highest tolerable dose of romidepsin that can be given in combination with ifosfamide, carboplatin, etoposide (ICE) to patients with PTCL. The safety of this drug combination will also be studied.

Romidepsin is designed to stop the growth of cancer cells and block new blood vessels from forming around the cancer cells. This may cause the cancer cells to die.

Ifosfamide and etoposide are designed to slow or stop the growth of cancer cells.

Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Romidepsin Drug: Ifosfamide Drug: Mesna Drug: Carboplatin Drug: Etoposide Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Romidepsin (ISTODAX®) Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Actual Study Start Date : October 2012
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: Romidepsin + ICE

Starting dose of Romidepsin: 8 mg/m2 by vein on Days 1 and 4 of a 14 Day cycle.

Ifosfamide plus Mesna: 5 gm/m2 for both given by vein over 24 hours on Day 1 of a 14 Day cycle.

Mesna: 2 gm/m2 given by vein given over 12 hours on Day 1 of a 14 Day cycle. Starts after completion of Ifosfamide plus Mesna administration.

Carboplatin: mg to equal target area under curve (AUC) by Calvert equation of 5 mg/ml/min with a maximum of 750 mg, given by vein over 1 hour on Day 1 of a 14 Day cycle.

Etoposide: 100 mg/m2 given by vein over 2 hours on Days 1 - 3 of a 14 Day cycle.

Drug: Romidepsin
Starting Dose: 8 mg/m2 by vein on Days 1 and 4 of a 14 Day cycle.
Other Names:
  • Istodax
  • Depsipeptide
  • FK228
Drug: Ifosfamide
5 gm/m2 by vein on Day 1 of a 14 Day cycle.
Other Name: Ifex
Drug: Mesna

5 gm/m2 by vein given with Ifosfamide over 24 hours on Day 1 of a 14 Day cycle.

2 gm/m2 by vein given over 12 hours starting after completion of ifosfamide plus MESNA on Day 1 of a 14 Day cycle.

Other Name: Mesnex
Drug: Carboplatin
mg to equal target area under curve (AUC) by Calvert equation of 5 mg/ml/min with a maximum of 750 mg by vein on Day 1 of a 14 Day cycle.
Other Name: Paraplatin
Drug: Etoposide
100 mg/m2 by vein on Days 1 - 3 of a 14 Day cycle.
Other Name: VePesid

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Romidepsin Plus ICE [ Time Frame: 21 days ]
    Maximum tolerated dose (MTD) is dose at which 20% of patients experience a dose limiting toxicity (DLT). DLT defined as drug-related adverse event with attribution of possible, probable, or definite and fulfilling one of following criteria. DLT assessment during cycle 1 of therapy. Adverse event grade 3 or 4 non-hematologic toxicity attributed to romidepsin that cannot be controlled or prevented by supportive care. Grade 4 thrombocytopenia or neutropenia that lasts for more than 14 days.

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) of Romidepsin Plus ICE [ Time Frame: 14 days after the last dose of study drug ]

    Response classified per these criteria as complete response (CR), partial remission (PR), stable disease (SD), and progressive disease (PD).

    Standard response criteria from the revised lymphoma response criteria used to assess response.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Relapsed or refractory TCL status including diagnoses of peripheral TCL-NOS, angioimmunoblastic TCL, anaplastic large cell lymphoma, hepatosplenic TCL, enteropathy-associated TCL, or mycosis fungoides(MF)/cutaneous TCL with transformation to systemic TCL.
  2. Patients must have received at least one chemotherapy regimen which contained doxorubicin.
  3. At least one 1.5 cm bidimensional measurable lesion or bone marrow positivity of TCL.
  4. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
  5. Lab criteria of absolute neutrophil count (ANC) >/= 1000 cells/mm3, platelets >/= 80,000 cells/mm3 if baseline bone marrow negative for TCL involvement and platelets >/= 20,000 cells/mm3 if baseline bone marrow positive for TCL involvement, bilirubin </= 2 x upper limits of normal (ULN) (Gilbert's </= 3 x ULN), creatinine </= 1.5 x ULN, and ALT and AST </= 3 x ULN.
  6. Negative pregnancy test for females of childbearing potential within 7 days prior to start of treatment. Patients of reproductive potential must follow accepted birth control methods which include hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence during treatment and for 3 months after completion of treatment.
  7. Age of >/= 18 years.
  8. Voluntarily signed Institutional Review Board (IRB) approved informed consent document (ICD) before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

  1. History of another malignancy not in remission for at least 2 yrs (except non-melanoma skin cancer, stage 0 melanoma, localized prostate cancer, cervical cancer in situ)
  2. Known active Central Nervous System (CNS) lymphoma.
  3. Ejection fraction (EF) of < 40%, myocardial infarction (MI) within past 3 months, uncontrolled angina, severe uncontrolled ventricular arrythmias, or ECG evidence of acute ischemia.
  4. Grade 3 infection within 2 weeks of first dose romidepsin plus ICE.
  5. Pregnant or lactating.
  6. Receipt of another investigational drug within 14 days of enrollment.
  7. Patients with previous hypersensitivity reactions to the study drugs and components (ex: podophyllum and povidone).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590732

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Principal Investigator: Michelle A. Fanale, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01590732     History of Changes
Other Study ID Numbers: 2012-0183
NCI-2012-00847 ( Registry Identifier: NCI CTRP )
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Peripheral T-Cell Lymphoma
Relapsed or refractory T-Cell Lymphoma
Peripheral TCL-NOS
Angioimmunoblastic TCL
Anaplastic large cell lymphoma
Hepatosplenic TCL
Enteropathy-associated TCL

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Etoposide phosphate
Isophosphamide mustard
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Protective Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic