NCT01590732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

October 29, 2012

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

5.5 years

First QC Date

May 1, 2012

Last Update Submit

September 17, 2018

Conditions

Mycosis FungoidesRecurrent Anaplastic Large Cell LymphomaRecurrent Angioimmunoblastic T-Cell LymphomaRecurrent Enteropathy-Associated T-Cell LymphomaRecurrent Hepatosplenic T-Cell LymphomaRecurrent Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedRefractory Anaplastic Large Cell LymphomaRefractory Angioimmunoblastic T-Cell LymphomaRefractory Enteropathy-Associated T-Cell LymphomaRefractory Hepatosplenic T-Cell LymphomaRefractory Peripheral T-Cell Lymphoma, Not Otherwise Specified

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose

    Up to 4 weeks post treatment

  • Incidence of adverse events

    Up to 4 weeks post treatment

Secondary Outcomes (2)

  • Overall response rate

    Up to 5.5 years

  • Complete response

    Up to 5.5 years

Study Arms (1)

Treatment (romidepsin, ifosfamide, carboplatin, etoposide)

EXPERIMENTAL

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.

Drug: CarboplatinDrug: EtoposideDrug: IfosfamideDrug: Romidepsin

Interventions

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Treatment (romidepsin, ifosfamide, carboplatin, etoposide)
EtoposideDRUG

Given IV

Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16-213, VP-16, VP-16-213
Treatment (romidepsin, ifosfamide, carboplatin, etoposide)
IfosfamideDRUG

Given IV

Also known as: 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
Treatment (romidepsin, ifosfamide, carboplatin, etoposide)
RomidepsinDRUG

Given IV

Also known as: 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
Treatment (romidepsin, ifosfamide, carboplatin, etoposide)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 29622656DERIVED

Related Links

MeSH Terms

Conditions

Mycosis FungoidesLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyEnteropathy-Associated T-Cell LymphomaLymphoma, T-Cell

Interventions

CarboplatinEtoposideIfosfamideromidepsinDepsipeptidesLactones

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, CutaneousLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathy

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPeptides, CyclicMacrocyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Michelle Fanale

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 3, 2012

Study Start

October 29, 2012

Primary Completion

May 2, 2018

Study Completion

May 2, 2018

Last Updated

September 19, 2018

Record last verified: 2018-09

Locations

US(1)