Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level

Trial ID or NCT#

NCT01396070

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting.

Official Title

Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Biopsy-proven MF/SS, stage IB-IVB, and failed one standard systemic therapy. Skin biopsy must be within 3 months of beginning study medication - At least the following wash-out from prior treatments: - ≥ 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-cancer investigational agents (including monoclonal antibody) - > 3 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox and phototherapy - > 2 wks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod) - At least 18 years of age - ECOG performance status of ≤ 2 - Must be able to commit to study schedule - Absolute neutrophil count (ANC) ≥ 1000/uL - Platelets ≥ 50,000/uL - Bilirubin ≤ 2X upper limit of normal (ULN) (EXCEPTION: Gilbert's disease ≤ 3X ULN) - Serum creatinine ≤ 2X ULN - Alanine aminotransferase (ALT) ≤ 3X ULN - Aspartate aminotransferase (AST) ≤ 3X ULN - Negative serum beta-HCG pregnancy test result within 7 days of first treatment, if a woman of childbearing potential - Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
  1. - Mycosis fungoides (MF) with limited disease (stage IA) or central nervous system (CNS) disease - Systemic or topical concomitant corticosteroid use for treatment of skin disease (EXCEPTION: Oral prednisone allowed at ≤ 10 mg/day) - Known Grade 3 or higher (per NCI CTCAE v4.0 criteria) active systemic or cutaneous viral, bacterial, or fungal infection - Known to be Hepatitis B or Hepatitis C antibody positive - HIV-positive with have a measurable viral load while on antiretroviral medication - Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation. - History of other malignancies during the past 3 years (EXCEPTIONS: non-melanoma skin cancer; curatively treated localized prostate cancer; curatively treated localized breast cancer; resected thyroid cancer; cervical intraepithelial neoplasia; or cervical carcinoma in situ on biopsy). - Pregnant - Breastfeeding - Congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria. - Any serious underlying medical condition that would impair subject's ability to receive or tolerate the planned treatment. - Dementia or altered mental status that would preclude subject's understanding and rendering of informed consent.
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Investigator(s)

Youn H Kim, MD
Youn H Kim, MD
Dermatologic oncologist, Cutaneous oncology specialist, Dermatologist
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)
Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Lymphoma specialist, Medical oncologist, Multiple myeloma specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Christina Kong
Christina Kong
Pathologist, Cytopathologist, Surgical pathologist
Professor of Pathology
Seema Nagpal, MD
Seema Nagpal, MD
Neuro-oncologist
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery
Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology
Richard Hoppe
Richard Hoppe
Radiation oncologist
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Contact us to find out if this trial is right for you.

Contact

ccto-office@stanford.edu
650-498-7061

View on ClinicalTrials.gov