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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396070
First Posted: July 18, 2011
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Youn Kim, Stanford University
  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.

Condition Intervention Phase
Non-Hodgkin Lymphoma (NHL) Cutaneous Lymphoma Cutaneous T-cell Lymphoma (CTCL) Mycosis Fungoides Sezary Syndrome Drug: Brentuximab vedotin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level

Resource links provided by NLM:


Further study details as provided by Youn Kim, Stanford University:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: 2 years ]
    Overall response rate of brentuximab vedotin in this study population.


Secondary Outcome Measures:
  • Overall Stable Disease Rate [ Time Frame: 2 years ]

    Overall Stable Disease Rate (SD) in this study population.

    3 subjects were not evaluable.


  • Overall Partial Response Rate [ Time Frame: 2 years ]

    Overall Partial Response Rate (PR) in this study population.

    3 subjects were not evaluable.


  • Overall Non-Evaluable Response [ Time Frame: 4 weeks ]

    Overall Non-Evaluable Response of full patient population

    3 subjects were not evaluable.



Enrollment: 36
Study Start Date: May 2011
Study Completion Date: May 2016
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab vedotin
Novel antibody-drug conjugate, 1.8 mg/kg intravenously every 3 weeks
Drug: Brentuximab vedotin

1.8 mg/kg by IV every 3 weeks for a maximum of 16 doses (8 cycles).

Brentuximab vedotin is an antibody conjugate, consisting of the chimeric IgG1 anti-CD30 antibody cAC10; the microtubule disrupting agent monomethyl auristatin E (MMAE); a protease-cleavable linker that covalently attaches MMAE to cAC10.

Other Names:
  • Adcetris
  • SGN-35

Detailed Description:

This phase 2 exploratory study will evaluate the clinical response of brentuximab vedotin in MF and SS, where tumor cells express variable levels of CD30 target molecule.

The primary objective is to explore the biologic activity of brentuximab vedotin in patients with MF and SS, the most common types of cutaneous T-cell lymphoma (CTCL), where expression of CD30 is variable. Brentuximab vedotin has significant biologic activity in Hodgkin's disease (HD) where only a small numbers of CD30 positive tumor cells are present, as well as in lymphomas with large numbers of CD30-expressing tumor cells such as systemic anaplastic large cell lymphoma (sALCL). The subject grouping by CD30 expression levels (low, intermediate, high) is for accrual purposes only, to ensure that a wide range of CD30 expression is studied.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396070


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Youn Kim
Seattle Genetics, Inc.
Investigators
Principal Investigator: Youn H Kim Stanford University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Youn Kim, The Joanne and Peter Haas, Jr, Professor for Cutaneous Lymphoma Research, Stanford University
ClinicalTrials.gov Identifier: NCT01396070     History of Changes
Other Study ID Numbers: IRB-21324
LYMNHL0089 ( Other Identifier: OnCore )
SU-06212011-7946 ( Other Identifier: Stanford University )
First Submitted: July 14, 2011
First Posted: July 18, 2011
Results First Submitted: December 28, 2016
Results First Posted: April 5, 2017
Last Update Posted: April 5, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphoma
Syndrome
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs