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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose
level of romidepsin based on when you join this study. Up to 4 dose levels of romidepsin
will be tested. Between 3-10 participants will be enrolled at each dose level. The first
group of participants will receive the lowest dose level. Each new group will receive a
higher dose than the group before it, if no intolerable side effects were seen. This will
continue until the highest tolerable dose of romidepsin is found.

All participants will receive the same dose level of ifosfamide, carboplatin, and etoposide.

Study Drug Administration:

Each Cycle is 14 days.

On Day 1:

- You will receive romidepsin by vein over 4 hours.

- You will receive ifosfamide by vein over 24 hours.

- You will receive mesna by vein over 24 hours. This infusion will begin 12 hours after
the end of the ifosfamide infusion. Mesna is given to help reduce the risk of
bladder-related side effects.

- You will receive carboplatin by vein over 1 hour.

- You will receive etoposide by vein over 2 hours.

On Days 2-3, you will receive etoposide by vein over 2 hours.

On Day 4, you will receive romidepsin by vein over 4 hours.

If needed, you will receive magnesium and potassium replacements.

Study Visits:

On Day 1 of every cycle:

- You will have a physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- You will have an ECG.

- You will be asked about any side effects you may be having.

Every week, blood (about 2 tablespoons) will be drawn for routine tests.

Between Days 7-14 of Cycles 2, 4, and 6, you may have a CT and PET/CT to check the status of
the disease.

Length of Study Drug Administration:

You may receive up to 6 cycles. You will no longer be able to take the study drug
combination if the disease gets worse, if intolerable side effects occur, or if you are
unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-study visit.

End-of-Study Visit:

About 14 days after the last dose of study drug:

- You will have a physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- You may have a CT and PET/CT to check the status of the disease.

- You may have a bone marrow biopsy/aspirate to check the status of the disease.

- You will have an ECG.

- You will be asked about any side effects you may be having.

This is an investigational study. Romidepsin is FDA approved and commercially available for
the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least 1
prior systemic therapy. ICE is FDA approved and commercially available for the treatment of
several types of lymphoma, including relapsed and refractory Hodgkin's lymphoma. The
combination of romidepsin and ICE for the treatment of PTCL is investigational.

Up to 30 participants will take part in this study. All will be enrolled at MD Anderson.


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.

4. Eastern Cooperative Oncology Group (ECOG) performance status
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
ULN, and ALT and AST
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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

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.

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Michelle A. Fanale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2012-0183

NCT ID:

NCT01590732

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Peripheral T-Cell Lymphoma
  • PTCL
  • Relapsed or refractory T-Cell Lymphoma
  • TCL
  • Peripheral TCL-NOS
  • Angioimmunoblastic TCL
  • Anaplastic large cell lymphoma
  • Hepatosplenic TCL
  • Enteropathy-associated TCL
  • Romidepsin
  • Istodax
  • Depsipeptide
  • FK228
  • Etoposide
  • VePesid
  • Carboplatin
  • Paraplatin
  • Mesna
  • Mesnex
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

Name

Location

UT MD Andreson Cancer Center Houston, Texas  77030