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CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

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

Trial ID or NCT#

NCT01396070

Status

NOT 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:

- 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:

- 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.

View All Criteria

Investigator(s)

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)

Seema Nagpal, MD

Neuro-oncologist

Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery

Richard Hoppe

Radiation oncologist

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Sunil Arani Reddy

Medical oncologist, Cutaneous oncology specialist

Clinical Assistant Professor, Medicine - Oncology

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

Pathologist, Cytopathologist, Surgical pathologist

Professor of Pathology

CONTACT

Ccto-office@stanford.edu
(650) 498-7061

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

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

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

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To: