Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome

NCT00466921 | Completed Phase 2 Results DMC

• 3 other identifiers: NU 04H5P30CA060553NU-04H5
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Lenalidomide may stop the growth of mycosis fungoides/Sezary syndrome by blocking blood flow to the cancer. PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with relapsed mycosis fungoides/Sezary syndrome.

Conditions

Lymphoma

Keywords

recurrent mycosis fungoides/Sezary syndrome; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome

Outcome Measures

Primary Outcomes (3)

• Response to Treatment

  In general response to treatment is defined as either complete response (CR) or partial response (PR) assessed using Composite Assessment (CA) of index lesion disease severity and is defined as the following: CR =CA ratio=0/no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (\< 5% Sézary cells=not significant). Skin biopsy is required for documentation of CR. Confirmatory CT scans are required, if baseline CTs were abnormal. PR= CA ratio ≥0.5/no new clinically abnormal lymph nodes/no progression of existing clinically abnormal lymph nodes (\<25%)/no new cutaneous tumors/no new pathologically positive lymph nodes or visceral disease in an area previously documented as-ve for at least 4 weeks. In patients with circulating Sézary cells at least a 50% reduction of malignant lymphocytes is required.

  After cycle 4 of treatment (1 cycle =28 days)

• Progression-free Survival (PFS)

  PFS is defined from the time of treatment initiation until documentation of progressive disease or death from any cause. Progressive disease is defined as (PD) ≥25% increase in CA ratio, ≥25% increase in no. or area of clinically abnormal lymph nodes/new tumors/new pathologically positive lymph nodes/visceral disease/an increase \>25% in no. of Sézary cells.

  From time of treatment initiation until progression or death from any cause (up to a possible maximum of approximately 6 years)

• Duration of Response (DOR)

  DOR is defined as time of initial documentation of response to the time of documentation of progression in patients who achieve either a complete response (CR) and partial response (PR)

  From time of initial response until progressive disease (up to approximately 1 year)

Secondary Outcomes (1)

• Number of Patients Who Experience Toxicity as Assessed by NCI CTCAE v3.0

  From treatment initiation until up to 30 days post treatment with possible 4 cycles of initial treatment (1 cycle =28 days) and up to 2 further years of treatment permitted if meeting response criteria

Other Outcomes (2)

• Specific Immune Effector Cell Recruitment and Augmentation of Antitumor Response at Baseline and Day 15 of Course 1 (Northwestern University Only)

  After all patients have completed thru day 15 of course 1.

• Correlation of Antiangiogenetic and Costimulatory Effects With Clinical Activity at Baseline and After Course 1

  After all patients have completed 1 course

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Drug: lenalidomide

Interventions

lenalidomide DRUG

10 mg daily orally administered on days 1 - 21 followed by 7 days rest of a 28-day cycle, increasing dose by 5 mg every cycle, up to a maximum of 25 mg.

Lenalidomide

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed mycosis fungoides/Sézary syndrome * Stage IA-IVB disease * Must have failed ≥ 1 prior topical treatment, including any of the following: * Steroids * Nitrogen mustard * Retinoids * Phototherapy * Photochemotherapy * Radiotherapy * Total skin electron beam * Measurable disease with ≥ 1 indicator lesion designated prior to study entry * Erythrodermic patients are eligible PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * WBC ≥ 3,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2.2 mg/dL * AST and ALT ≤ 2 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile women must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy * Fertile men must use effective contraception during and for ≥ 4 weeks after completion of study therapy * No other malignancy within the past 5 years except treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, or surgically removed melanoma in situ of the skin (stage 0), with histologically confirmed free margins of excision and no current evidence of disease * No acute infection requiring systemic treatment * No known allergic reaction or hypersensitivity to thalidomide PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior topical therapy, systemic chemotherapy, or biological therapy * No prior stem cell transplantation * No other concurrent systemic antipsoriatic or anticancer therapies, including radiotherapy, thalidomide, or other investigational agents * No other concurrent topical agents except emollients

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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Stanford Cancer Center

Stanford, California, 94305-5824, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• Querfeld C, Rosen ST, Guitart J, Duvic M, Kim YH, Dusza SW, Kuzel TM. Results of an open-label multicenter phase 2 trial of lenalidomide monotherapy in refractory mycosis fungoides and Sezary syndrome. Blood. 2014 Feb 20;123(8):1159-66. doi: 10.1182/blood-2013-09-525915. Epub 2013 Dec 11.

  PMID: 24335103 DERIVED

MeSH Terms

Conditions

Lymphoma; Mycosis Fungoides; Sezary Syndrome

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Clinical Trials Office
• Organization: Northwestern University

312-695-1301

Study Officials

• Timothy M. Kuzel, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

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

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: April 19, 2005
• Primary Completion: April 5, 2010
• Study Completion: May 17, 2013
• Last Updated: December 1, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-10

Locations

US (3)