TSEB and Brentuximab for Treatment of Mycosis Fungoides & Sezary Syndrome

Completed · Phase 1

Conditions studied: Mycosis Fungoides, Sézary Syndrome

In brief

The purpose of this study is to evaluate the cutaneous toxicity and treatment response associated with administering concurrent TSEB and brentuximab vedotin in patients with mycosis fungoides or Sézary Syndrome.

Key facts

Study ID

NCT02822586

Run by

Virginia Commonwealth University

People needed

5

Starts

2016-12-19

Expected to finish

2019-04-29

Last updated by the study team

2019-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed CD30-positive (defined in this study as ≥ 1% expression) Mycosis Fungoides (including large cell transformation variant) or Sezary Syndrome who have either:
• Received prior systemic therapy (for whom commercial supply of brentuximab vedotin is available) OR
• Not received prior systemic therapy (who will receive brentuximab vedotin free of charge)
• Any of the disease stages listed below
• Stage IB disease that meets one of the following criteria:
• Plaque disease (ie,T2b staging)
• Diffuse skin involvement with indication for TSEB (plaque disease with or without patches)
• Not appropriate for treatment with focal therapies
• One prior course of low-dose TSEB or one prior course of systemic chemotherapy regimens (excluding brentuximab)
• Stage IIA, IIB, or IIIA that meets ONE or BOTH of the following criteria:
• Patient is a candidate for treatment with low-dose TSEB
• Patient is a candidate for systemic therapy
• IIIB or IVA disease requiring systemic therapy
• Transformed CTCL
• Candidate for TSEB based on investigator determination
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3, if the performance status of 3 is due to skin disease involvement
• Adequate bone marrow function as defined below:
• Absolute neutrophil count (ANC) ≥ 1000/mm3
• Platelets > 75,000/mm3
• Hemoglobin ≥ 9 g/dL
• Note: Patients requiring transfusion to meet the hemoglobin requirement are not eligible for the study.
• Calculated creatinine clearance (CrCl) > 30 mL/min.
• Adequate hepatic function as defined below:
• Total bilirubin ≤ 1.5 x ULN for the laboratory
• Aspartate aminotransferase (AST) ≤ 2 x ULN for the laboratory

You may not qualify if…

• Previous TSEB therapy with total dose > 20 Gy
• Previous brentuximab treatment
• Any of the following within 4-3 weeks prior to initiating study treatment
• Systemic biologic therapy
• Monoclonal antibody
• Chemotherapy
• TSEB
• Phototherapy
• Other investigational therapy
• Anticancer topical therapy, including therapeutic doses of steroids, within 2 weeks prior to initiating study treatment
• Note: Topical steroids at doses intended for symptom management are permitted prior to study enrollment and may continue during study treatment.
• Peripheral sensory neuropathy or peripheral motor neuropathy ≥ grade 2 per NCI CTCAE v4.0
• Diabetic neuropathy (any grade)
• Demyelinating form of Charcot-Marie-Tooth Syndrome
• History of progressive multifocal leukoencephalopathy
• Active or clinically significant cardiac disease including any of the following:
• Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment
• Myocardial infarction within 6 months prior to initiating study treatment
• New York Heart Association (NYHA) class III or IV congestive heart failure (Appendix 4)
• Active ≥ grade 3 (per NCI CTCAE v4) viral, bacterial, or fungal infection within 2 weeks prior to initiation of study treatment
• Known human immunodeficiency virus (HIV) infection
• Known or suspected active hepatitis B or C infection
• Known cirrhosis
• Known Gilbert's Syndrome
• Planned ongoing treatment with another drug that may potentially have adverse interactions with brentuximab vedotin; if such a drug has been used, it must be discontinued at least 1 week prior to initiating study treatment (see Section 6.6); examples of potential interactions include:

Where it is running

• Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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