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

Primary Purpose

Non-Hodgkin Lymphoma (NHL), Cutaneous Lymphoma, Cutaneous T-cell Lymphoma (CTCL)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brentuximab vedotin
Sponsored by
Youn Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma (NHL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brentuximab vedotin

Arm Description

Novel antibody-drug conjugate, 1.8 mg/kg intravenously every 3 weeks

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
Overall response rate of brentuximab vedotin in this study population.

Secondary Outcome Measures

Overall Stable Disease Rate
Overall Stable Disease Rate (SD) in this study population. 3 subjects were not evaluable.
Overall Partial Response Rate
Overall Partial Response Rate (PR) in this study population. 3 subjects were not evaluable.
Overall Non-Evaluable Response
Overall Non-Evaluable Response of full patient population 3 subjects were not evaluable.

Full Information

First Posted
July 14, 2011
Last Updated
February 17, 2017
Sponsor
Youn Kim
Collaborators
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01396070
Brief Title
Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level
Official Title
Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Youn Kim
Collaborators
Seagen Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma (NHL), Cutaneous Lymphoma, Cutaneous T-cell Lymphoma (CTCL), Mycosis Fungoides, Sezary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brentuximab vedotin
Arm Type
Experimental
Arm Description
Novel antibody-drug conjugate, 1.8 mg/kg intravenously every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Brentuximab vedotin
Other Intervention Name(s)
Adcetris, SGN-35
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Overall response rate of brentuximab vedotin in this study population.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Stable Disease Rate
Description
Overall Stable Disease Rate (SD) in this study population. 3 subjects were not evaluable.
Time Frame
2 years
Title
Overall Partial Response Rate
Description
Overall Partial Response Rate (PR) in this study population. 3 subjects were not evaluable.
Time Frame
2 years
Title
Overall Non-Evaluable Response
Description
Overall Non-Evaluable Response of full patient population 3 subjects were not evaluable.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youn H Kim
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26195720
Citation
Kim YH, Tavallaee M, Sundram U, Salva KA, Wood GS, Li S, Rozati S, Nagpal S, Krathen M, Reddy S, Hoppe RT, Nguyen-Lin A, Weng WK, Armstrong R, Pulitzer M, Advani RH, Horwitz SM. Phase II Investigator-Initiated Study of Brentuximab Vedotin in Mycosis Fungoides and Sezary Syndrome With Variable CD30 Expression Level: A Multi-Institution Collaborative Project. J Clin Oncol. 2015 Nov 10;33(32):3750-8. doi: 10.1200/JCO.2014.60.3969. Epub 2015 Jul 20.
Results Reference
derived

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

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