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

NCT01396070 | Completed Phase 2 Results DMC

• 3 other identifiers: IRB-21324LYMNHL0089SU-06212011-7946
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Hodgkin Lymphoma (NHL); Cutaneous Lymphoma; Cutaneous T-cell Lymphoma (CTCL); Mycosis Fungoides; Sezary Syndrome

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Overall response rate of brentuximab vedotin in this study population.

  2 years

Secondary Outcomes (3)

• Overall Stable Disease Rate

  2 years

• Overall Partial Response Rate

  2 years

• Overall Non-Evaluable Response

  4 weeks

Study Arms (1)

Brentuximab vedotin

EXPERIMENTAL

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

Drug: Brentuximab vedotin

Interventions

Brentuximab vedotin DRUG

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.

Also known as: Adcetris, SGN-35

Brentuximab vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Youn Kim: lead
• Seagen Inc.: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 26195720 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Youn H Kim, MD
• Organization: Stanford University Medical Center

younkim@stanford.edu

650-521-3545

Study Officials

• Youn H Kim

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Joanne and Peter Haas, Jr, Professor for Cutaneous Lymphoma Research

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2016
• Last Updated: April 5, 2017
• Results First Posted: April 5, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)