Phase I Study of Romidepsin Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
This study is currently recruiting participants.
Verified February 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01590732
First received: May 1, 2012
Last updated: February 20, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Romidepsin Drug: Ifosfamide Drug: Mesna Drug: Carboplatin Drug: Etoposide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Drug Information available for:
Ifosfamide
Mesna
Etoposide
Carboplatin
Etoposide phosphate
Romidepsin
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Romidepsin + ICE
Starting dose of Romidepsin: 6 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: 6 mg/m2 by vein on Days 1 and 4 of a 14 Day cycle.
Other Names:
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- Patients must have received at least one chemotherapy regimen which contained doxorubicin.
- At least one 1.5 cm bidimensional measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- 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.
- 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.
- Age of >/= 18 years.
- 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:
- 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)
- Known active Central Nervous System (CNS) lymphoma.
- Ejection fraction (EF) of < 40%, myocardial infarction (MI) within past 3 months, uncontrolled angina, severe uncontrolled ventricular arrythmias, or ECG evidence of acute ischemia.
- Grade 3 infection within 2 weeks of first dose romidepsin plus ICE.
- Pregnant or lactating.
- Receipt of another investigational drug within 14 days of enrollment.
- Patients with previous hypersensitivity reactions to the study drugs and components (ex: podophyllum and povidone).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590732
Contacts
| Contact: Michelle A. Fanale, MD | 713-792-2806 |
Locations
| United States, Texas | |
| UT MD Andreson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
| Principal Investigator: | Michelle A. Fanale, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01590732 History of Changes |
| Other Study ID Numbers: | 2012-0183 |
| Study First Received: | May 1, 2012 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Mesna Etoposide Etoposide phosphate Isophosphamide mustard |
Romidepsin Ifosfamide Carboplatin Protective Agents Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013