Mycosis FungoidesPhase 1NCT01590732
Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma
A Phase 1 study testing Carboplatin, Etoposide and Ifosfamide in people with Mycosis Fungoides and Recurrent Anaplastic Large Cell Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides, Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma
- What is being tested?
- Carboplatin, Etoposide and Ifosfamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2012to 2 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Romidepsin (ISTODAX®) Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- 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
- Being tested
- Carboplatin, Etoposide, Ifosfamide, Romidepsin
- Medical subject headings
- Mycosis Fungoides, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Enteropathy-Associated T-Cell Lymphoma, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
EtoposideDrug
Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar
Given IV
IfosfamideDrug
Also called Asta Z 4942, Asta Z-4942, Cyfos, Holoxan
Given IV
RomidepsinDrug
Also called Antibiotic FR 901228, Depsipeptide, FK228, FR901228
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide; Drug: Romidepsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: Up to 4 weeks post treatment
Incidence of adverse events
Measured: Up to 4 weeks post treatment
Secondary outcomes (2)
Overall response rate
Point estimates along with 95% confidence intervals will be provided.
Measured: Up to 5.5 years
Complete response
Point estimates along with 95% confidence intervals will be provided.
Measured: Up to 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study start29 Oct 2012
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michelle Fanale, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590732
- Sponsor's protocol ID
- 2012-0183
- Other IDs
- NCI-2018-01827, 2012-0183, P30CA016672
- Status last verified
- Sep 2018
- First submitted
- 1 May 2012
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 29622656
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Romidepsin (ISTODAX®) Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01590732
- Acronym / sponsor ID
- 2012-0183
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Oct 2012 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (romidepsin, ifosfamide, carboplatin, etoposide) | Experimental | Drug: Carboplatin, Drug: Etoposide, Drug: Ifosfamide, Drug: RomidepsinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinAlso: Blastocarb, Carboplat, Carboplatin Hexal, CarboplatinoGiven IV | Drug | Treatment (romidepsin, ifosfamide, carboplatin, etoposide) |
| EtoposideAlso: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, ToposarGiven IV | Drug | Treatment (romidepsin, ifosfamide, carboplatin, etoposide) |
| IfosfamideAlso: Asta Z 4942, Asta Z-4942, Cyfos, HoloxanGiven IV | Drug | Treatment (romidepsin, ifosfamide, carboplatin, etoposide) |
| RomidepsinAlso: Antibiotic FR 901228, Depsipeptide, FK228, FR901228Given IV | Drug | Treatment (romidepsin, ifosfamide, carboplatin, etoposide) |
Primary outcome
Maximum tolerated dose
Time frame: Up to 4 weeks post treatment
Incidence of adverse events
Time frame: Up to 4 weeks post treatment
2 secondary outcomes
Overall response rate
Time frame: Up to 5.5 years
Complete response
Time frame: Up to 5.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Derived from this study: PubMed 29622656Strati 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.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Fanale principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carboplatin, Etoposide and Ifosfamide in people with Mycosis Fungoides and Recurrent Anaplastic Large Cell Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: Up to 4 weeks post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.