Mycosis Fungoides Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
| Not yet recruiting |
NCT02881749 -
Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides
|
Phase 2 | |
| Completed |
NCT00051012 -
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
|
Phase 4 | |
| Terminated |
NCT03789864 -
Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides
|
N/A | |
| Recruiting |
NCT02848274 -
ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome
|
||
| Recruiting |
NCT00177268 -
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
|
||
| Recruiting |
NCT05357794 -
Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides
|
Phase 2 | |
| Completed |
NCT04955340 -
A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat
|
Phase 1 | |
| Recruiting |
NCT04960618 -
Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome
|
Phase 2 | |
| Completed |
NCT02883517 -
Cell-free Circulating DNA in Primary Cutaneous Lymphomas
|
||
| Active, not recruiting |
NCT02953301 -
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
|
Phase 2 | |
| Completed |
NCT00254332 -
Effect of Denileukin Diftitox on Immune System in CTCL Patients
|
N/A | |
| Completed |
NCT02296164 -
Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
|
||
| Recruiting |
NCT05680558 -
Photopheresis in Early-stage Mycosis Fungoides
|
Phase 2 | |
| Completed |
NCT00038376 -
Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies
|
Phase 2 | |
| Completed |
NCT00168064 -
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
|
Phase 2 | |
| Recruiting |
NCT05879458 -
Ritlecitinib in CTCL
|
Phase 2 | |
| Recruiting |
NCT05414500 -
Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides
|
Phase 1 | |
| Recruiting |
NCT05904522 -
Histopathological Changes in Mycosis Fungoides
|
N/A | |
| Recruiting |
NCT04256018 -
Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
|
Phase 2 |