Lymphomatoid Papulosis, Mycosis Fungoides, Sezary Syndrome
Conditions
Keywords
Brentuximab Vedotin, 18-147
Brief summary
The purpose of this study is to test any good and bad effects of the study drug called brentuximab vedotin at a lower dose than is FDA-approved.
Interventions
DRUGbrentuximab vedotin
MF/SS Brentuximab vedotin 0.9 mg/kg 0R 1.2 mg/kg.
Sponsors
Memorial Sloan Kettering Cancer Center
Seagen Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Following identification of a promising dose after the completion of the full Cohort 1 Simon two stage design, enrollment will initiate onto cohort 2 at the dose found to be promising in cohort 1. If neither dose is found promising, cohort 2 will not start.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Mycosis fungoides (MF) and Sezary Syndrome (SS) 1. Pathologically confirmed mycosis fungoides/sezary syndrome at the enrolling institution, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher ° CD30 negative mycosis fungoides patients are eligible. 2. Age ≥ 18 years 3. ECOG Performance Score ≤ 2 4. For Cohort 1, patients who have not received brentuximab vedotin are eligible. 5. For Cohort 2, patients who have previously had brentuximab vedotin for MF/SS are eligible. Patients previously treated on Cohort 1 who were discontinued due to toxicity are not eligible for Cohort 2. 6. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment. ° See section 6.2 Subject
Exclusion criteria
for guidelines regarding adjuvant and maintenance therapy for prior malignancy. 7. Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary suffering, after discussion with PI. 8. If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \>200 within 7 days prior to C1D1. 9. Females of childbearing potential must be on acceptable form of birth control per instutional standard. Lymphomatoid papulosis (LyP) 1. Pathologically confirmed lymphomatoid papulosis at the enrolling institution 2. Requiring systemic treatment per investigator's discretion 3. Age ≥ 18 years 4. ECOG Performance Score ≤ 2 5. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment. 6. Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary suffering. 7. If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count \>200 within 7 days prior to C1D1. 8. Females of childbearing potential must be on acceptable form of birth control per institutional standard
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response | 1 year | measure best overall response during treatment by the global response score, which incorporates the mSWAT, as well as CT scan for patients with baseline nodal/visceral involvement and flow cytometry for patients with baseline positive peripheral flow cytometry |
Countries
United States
Contacts
CONTACTAlison Moskowitz, MD
CONTACTPatricia Myskowski, MD
PRINCIPAL_INVESTIGATORAlison Moskowitz, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed