Vorinostat With or Without Bortezomib in Treating Patients With Refractory or Recurrent Stage IIB, Stage III, or Stage IV Cutaneous T-Cell Lymphoma

NCT01386398 | Withdrawn Phase 3

• 3 other identifiers: EORTC-21082EU-21116EUDRACT-2009-011021-13
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether vorinostat is more effective when given alone or when given together with bortezomib in treating patients with refractory or recurrent cutaneous T-cell lymphoma. PURPOSE: This randomized phase III trial is studying how well vorinostat works when given alone compared with vorinostat given together with bortezomib in treating patients with refractory or recurrent stage IIB, stage III, or stage IV cutaneous T-cell lymphoma.

Conditions

Lymphoma

Keywords

stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent mycosis fungoides/Sezary syndrome; recurrent cutaneous T-cell non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (6)

• Overall survival

• Response rate

• Time to progression

• Duration of response

• Second cancers

Interventions

bortezomib DRUG

vorinostat DRUG

laboratory biomarker analysis OTHER

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed advanced cutaneous T-cell lymphoma (CTCL), including its variants mycosis fungoides and Sézary syndrome * Stage IIB-IV disease * Relapsed or refractory disease, including any of the following: * Patients with clinical progression following EORTC-21081 protocol treatment * Intolerant to ≥ 1 prior intravenous chemotherapy, including denileukin diftitox, antibodies or antibody conjugates, or any other systemic therapy * No CNS involvement PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Absolute neutrophil count \> 1.5 x 10\^9/L\* * Platelet count \> 100 x 10\^9/L\* * Hemoglobin \> 9 g/dL\* * WBC \> 3 x 10\^9/L\* * Bilirubin ≤ 1.5 times upper limit of normal (ULN)\* * AST and ALT ≤ 3 times ULN (in case of liver infiltration ≤ 5 x ULN)\* * Serum creatinine ≤ 2.0 mg/dL\* * Calculated creatinine clearance ≥ 60 mL/min * Electrolytes (including potassium and magnesium) ≤ 1 times ULN\* * Not pregnant or nursing prior to the first dose of study treatment and until 4 weeks after the last study treatment * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study therapy * Able to swallow capsules and is able to take or tolerate oral medication on a continuous basis * No New York Heart Association class III-IV disease * None of the following known conditions: * Infectious disease * Autoimmune disease * Immunodeficiency * No known or active HIV and/or hepatitis A, B, or C infection * No NCI CTC grade 1 peripheral sensory neuropathy with pain or peripheral sensory or motor neuropathy ≥ grade II * No other malignancy within the past 5 years * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule NOTE: \*Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable, except for renal function. PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Must have completely recovered from previous treatment toxicity * No prior splenectomy or splenic irradiation * No prior bortezomib and/or histone deacetylase inhibitors (including vorinostat \[SAHA\]) * More than 4 weeks since prior chemotherapy, immunotherapy, radiotherapy, or surgery * In case of clear progression during previous treatment, 2 weeks of wash-out is enough * No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery (except biopsies) * No concurrent steroid (prednisone or equivalent) dose \> 20 mg/day * Prednisone ≤ 20 mg/day for treatment of disorders other than CTCL allowed * No concomitant use of other histone deacetylase inhibitors (e.g., valproic acid)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Related Publications (1)

• Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

  PMID: 32632956 DERIVED

MeSH Terms

Conditions

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

Interventions

Bortezomib; Vorinostat

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Study Officials

• Pablo Luis Ortiz-Romero

  Hospital Universitario 12 de Octubre

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 1, 2011
• Last Updated: January 21, 2015

Record last verified: 2015-01