Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma
Primary Purpose
Mycosis Fungoides, Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Etoposide
Ifosfamide
Romidepsin
Sponsored by
About this trial
This is an interventional treatment trial for Mycosis Fungoides
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory T cell lymphoma (TCL) status including diagnoses of peripheral TCL-not otherwise specified (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 or bone marrow positivity of TCL
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- 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 upper limit of normal [ULN])
- Creatinine =< 1.5 x ULN
- Alanine aminotransferase (ALT) and aminotransferase (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
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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 years (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 arrthymias, or electrocardiogram (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)
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (romidepsin, ifosfamide, carboplatin, etoposide)
Arm Description
Participants receive romidepsin IV over 4 hours on days 1 and 4, ifosfamide IV over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on day 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Maximum tolerated dose
Incidence of adverse events
Secondary Outcome Measures
Overall response rate
Point estimates along with 95% confidence intervals will be provided.
Complete response
Point estimates along with 95% confidence intervals will be provided.
Full Information
NCT ID
NCT01590732
First Posted
May 1, 2012
Last Updated
September 17, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01590732
Brief Title
Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma
Official Title
Phase I Study of Romidepsin (ISTODAX®) Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 29, 2012 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This phase I trial studies the best dose and side effects of romidepsin when given in combination with ifosfamide, carboplatin, and etoposide in treating participants with peripheral T-cell lymphoma that has come back or does not respond to treatment. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving romidepsin, ifosfamide, carboplatin, and etoposide may work better in treating participants with peripheral T-cell lymphoma.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the safety profile of romidepsin given before and after ifosfamide, carboplatin, etoposide (ICE) chemotherapy for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
II. To determine the maximum tolerated dose (MTD), if reached, of romidepsin administered in combination with ICE chemotherapy in patients with relapsed or refractory PTCL.
SECONDARY OBJECTIVES:
I. To determine the overall response rate (ORR) and complete response (CR) rate in patients with relapsed or refractory PTCL.
OUTLINE: This is a dose-escalation study of romidepsin.
Participants receive romidepsin intravenously (IV) over 4 hours on days 1 and 4, ifosfamide IV over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on day 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up within 2-4 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycosis Fungoides, Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma, Recurrent Hepatosplenic T-Cell Lymphoma, Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified, Refractory Anaplastic Large Cell Lymphoma, Refractory Angioimmunoblastic T-Cell Lymphoma, Refractory Enteropathy-Associated T-Cell Lymphoma, Refractory Hepatosplenic T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (romidepsin, ifosfamide, carboplatin, etoposide)
Arm Type
Experimental
Arm Description
Participants receive romidepsin IV over 4 hours on days 1 and 4, ifosfamide IV over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on day 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16-213, VP-16, VP-16-213
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Other Intervention Name(s)
Asta Z 4942, Asta Z-4942, Cyfos, Holoxan, Holoxane, Ifex, IFO, IFO-Cell, Ifolem, Ifomida, Ifomide, Ifosfamidum, Ifoxan, IFX, Iphosphamid, Iphosphamide, Iso-Endoxan, Isoendoxan, Isophosphamide, Mitoxana, MJF 9325, MJF-9325, Naxamide, Seromida, Tronoxal, Z 4942, Z-4942
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Romidepsin
Other Intervention Name(s)
Antibiotic FR 901228, Depsipeptide, FK228, FR901228, Istodax, N-[(3S,4E)-3-Hydroxy-7-mercapto-1-oxo-4-heptenyl]-D-valyl-D-cysteinyl-(2Z)-2-amino-2-butenoyl-L-valine, (4->1) Lactone, Cyclic
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Time Frame
Up to 4 weeks post treatment
Title
Incidence of adverse events
Time Frame
Up to 4 weeks post treatment
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Point estimates along with 95% confidence intervals will be provided.
Time Frame
Up to 5.5 years
Title
Complete response
Description
Point estimates along with 95% confidence intervals will be provided.
Time Frame
Up to 5.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory T cell lymphoma (TCL) status including diagnoses of peripheral TCL-not otherwise specified (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 or bone marrow positivity of TCL
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
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 upper limit of normal [ULN])
Creatinine =< 1.5 x ULN
Alanine aminotransferase (ALT) and aminotransferase (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
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 years (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 arrthymias, or electrocardiogram (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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Fanale
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29622656
Citation
Strati P, Chihara D, Oki Y, Fayad LE, Fowler N, Nastoupil L, Romaguera JE, Samaniego F, Garg N, Feng L, Wesson ET, Ruben CE, Stafford MD, Nieto Y, Khouri IF, Hosing C, Horowitz SB, Kamble RT, Fanale MA. A phase I study of romidepsin and ifosfamide, carboplatin, etoposide for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Haematologica. 2018 Sep;103(9):e416-e418. doi: 10.3324/haematol.2018.187617. Epub 2018 Apr 5. No abstract available.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma
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