ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008

Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00436618
  Purpose

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying the side effects and how well everolimus works in treating patients with lymphoma that has relapsed or not responded to previous treatment.


Condition Intervention Phase
Leukemia
Lymphoma
Small Intestine Cancer
Drug: everolimus
Procedure: laboratory biomarker analysis
Phase II

MedlinePlus related topics:   Cancer    Intestinal Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma   

ChemIDplus related topics:   Everolimus    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Phase II Trial of RAD001 in Relapsed/Refractory Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed response, defined as complete response (CR), CR unconfirmed, or partial response (PR) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response (CR or PR) [ Designated as safety issue: No ]
  • Correlation of molecular effects of everolimus on proteins downstream of MTOR, such as phospho-S6 and cyclin D1, with response to therapy [ Designated as safety issue: No ]

Estimated Enrollment:   200
Study Start Date:   August 2005

Detailed Description:

OBJECTIVES:

Primary

  • Assess the tumor response in patients with relapsed or refractory indolent or aggressive non-Hodgkin's lymphoma (closed to accrual as of 8/24/07) or uncommon lymphoma (closed to accrual as of 6/1/07 with the exception of lymphoplasmacytic lymphoma [Waldenstrom's macroglobulinemia]), including Hodgkin's lymphoma, treated with everolimus.
  • Determine the toxicity of this drug in these patients.

Secondary

  • Evaluate overall survival, progression-free survival, and time to disease progression in patients treated with this drug.
  • Correlate known and unknown molecular markers with response in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (aggressive lymphoma [closed to accrual as of 8/24/07] vs indolent lymphoma vs uncommon lymphoma [closed to accrual as of 6/1/07 with the exception of lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia)]).

Patient receive oral everolimus daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood and tissue collection at baseline and periodically during study treatment for translational research studies. Blood and tissue samples are analyzed for biomarkers to study the effect of everolimus on lymphoma.

After completion of study treatment, patients are followed periodically for up to 5 years.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Biopsy-proven* relapsed or refractory lymphoma, including the following:

    • Aggressive lymphoma (closed to accrual as of 8/24/07)

      • Transformed lymphoma
      • Diffuse large B-cell lymphoma
      • Mantle cell lymphoma
      • Grade 3 follicular lymphoma
      • Precursor B-cell lymphoblastic leukemia/lymphoma
      • Mediastinal (thymic) large B-cell lymphoma
      • Burkitt's lymphoma/leukemia
      • Precursor T-cell lymphoblastic leukemia/lymphoma
      • Primary cutaneous anaplastic large cell lymphoma
      • Primary systemic type anaplastic large cell lymphoma
    • Indolent lymphoma

      • Small lymphocytic lymphoma/chronic lymphocytic leukemia
      • Grade 1 or 2 follicular lymphoma
      • Extranodal marginal zone B-cell lymphoma of MALT type
      • Nodal marginal zone B-cell lymphoma
      • Splenic marginal zone B-cell lymphoma
    • Uncommon lymphoma (closed to accrual as of 6/1/07 with the exception of lymphoplasmacytic lymphoma [Waldenstrom's macroglobulinemia])

      • Unspecified peripheral T-cell lymphoma
      • Anaplastic large cell lymphoma (T and null cell type)
      • Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia)
      • CNS lymphoma
      • Post-transplant lymphoproliferative disorder
      • Mycosis fungoides/Sezary syndrome
      • Hodgkin's lymphoma
      • Primary effusion lymphoma
      • Blastic NK-cell lymphoma
      • Adult T-cell leukemia/lymphoma
      • Nasal type extranodal NK/T-cell lymphoma
      • Enteropathy type T-cell lymphoma
      • Hepatosplenic T-cell lymphoma
      • Subcutaneous panniculitis-like T-cell lymphoma
      • Angioimmunoblastic T-cell lymphoma NOTE: *Biopsies performed < 6 months prior to study entry are allowed; biopsy-proven CNS lymphoma (at any time) does not require a re-biopsy in order to be eligible for this study
  • Previously treated disease

    • Patients with aggressive lymphoma (closed to accrual as of 8/24/07) OR Hodgkin's lymphoma must have received or be ineligible for potentially curative therapy, including stem cell transplantation
  • Measurable disease** by CT scan or MRI, defined by 1 of the following:

    • At least 1 unidimensionally measurable lesion > 2 cm in diameter

      • Skin lesions may be used if they meet this criterion and are photographed with a ruler
    • More than 5,000/mm³ tumor cells in the blood NOTE: **For patients with lymphoplasmacytic lymphoma without measurable lymphadenopathy, measurable disease may be defined by bone marrow lymphoplasmacytosis with > 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy AND quantitative IgM monoclonal protein > 1,000 mg/dL

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin ≥ 8 g/dL
  • Total bilirubin ≤ 2 times upper limit of normal (ULN) OR direct bilirubin ≤ 1.5 times ULN
  • AST ≤ 3 times ULN (5 times ULN if liver involvement is present)
  • Creatinine ≤ 2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to provide blood samples and portion of bone marrow aspirate and biopsy during study participation
  • Able to swallow intact study medication tablets
  • No other life-threatening illness (unrelated to tumor)
  • No serious non-malignant disease (e.g., active infection or other condition) that, in the opinion of the investigator, would preclude study participation
  • No other active malignancy requiring treatment or that would preclude study participation
  • No known HIV positivity

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 3 weeks since prior myelosuppressive chemotherapy or biologic therapy (unless the patient has recovered from the nadir of the previous treatment)
  • More than 3 weeks since prior radiotherapy (unless the acute side effects associated with therapy are resolved)
  • Concurrent stable (i.e., not increased within the past month) chronic doses of corticosteroids, with a maximum dose of 20 mg of prednisone per day, is allowed if prescribed for disorders other than lymphoma (e.g., rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or asthma)

    • Non-escalating doses of steroids at the lowest possible dosing level are allowed for CNS lymphoma
  • No other concurrent investigational ancillary therapy
  • No other concurrent chemotherapy, immunotherapy, or radiotherapy
  • No concurrent participation in any other clinical trial involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy) for symptom control or therapeutic intent
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436618

Locations
United States, Arizona
Mayo Clinic Scottsdale     Recruiting
      Scottsdale, Arizona, United States, 85259-5499
      Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Florida
Mayo Clinic - Jacksonville     Recruiting
      Jacksonville, Florida, United States, 32224
      Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115
      Contact: Clinical Trials Office - Dana-Farber/Harvard Cancer Center     617-582-8480        
United States, Minnesota
Mayo Clinic Cancer Center     Recruiting
      Rochester, Minnesota, United States, 55905
      Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        

Sponsors and Collaborators

Investigators
Study Chair:     Thomas E. Witzig, MD     Mayo Clinic    
Investigator:     Craig B. Reeder, MD     Mayo Clinic Scottsdale    
Investigator:     Han Win Tun, MD     Mayo Clinic    
Investigator:     Stephen M. Ansell, MD, PhD     Mayo Clinic    
Investigator:     Irene M. Ghobrial, MD     Dana-Farber Cancer Institute    
Investigator:     Thomas M. Habermann, MD     Mayo Clinic    
Investigator:     David J. Inwards, MD     Mayo Clinic    
Investigator:     Patrick Johnston, MD, PhD     Mayo Clinic    
Investigator:     Ivana Micallef, MD     Mayo Clinic    
Investigator:     William L. White, MD     Mayo Clinic    
Investigator:     Scott H. Kaufmann, MD, PhD     Mayo Clinic    
Investigator:     Joseph P. Colgan, MD     Mayo Clinic    
Investigator:     Luis F. Porrata, MD     Mayo Clinic    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000529824, MAYO-MC048G, MAYO-IRB-1042-05
First Received:   February 15, 2007
Last Updated:   July 26, 2008
ClinicalTrials.gov Identifier:   NCT00436618
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult Burkitt lymphoma  
recurrent adult Hodgkin lymphoma  
anaplastic large cell lymphoma  
angioimmunoblastic T-cell lymphoma  
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue  
nodal marginal zone B-cell lymphoma  
splenic marginal zone lymphoma  
small intestine lymphoma  
recurrent adult diffuse mixed cell lymphoma  
recurrent adult T-cell leukemia/lymphoma  
recurrent grade 3 follicular lymphoma  
recurrent marginal zone lymphoma  
refractory chronic lymphocytic leukemia  
recurrent small lymphocytic lymphoma
recurrent mycosis fungoides/Sezary syndrome
adult nasal type extranodal NK/T-cell lymphoma
Waldenstrom macroglobulinemia
recurrent adult diffuse large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent mantle cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
primary central nervous system lymphoma
post-transplant lymphoproliferative disorder
recurrent adult diffuse small cleaved cell lymphoma

Study placed in the following topic categories:
Sezary syndrome
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Central nervous system lymphoma, primary
Duodenal Neoplasms
Mycoses
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Leukemia, B-cell, chronic
Waldenstrom Macroglobulinemia
B-cell lymphomas
Leukemia, T-Cell
Gastrointestinal Neoplasms
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Leukemia, Lymphoid
Hodgkin's disease
Gastrointestinal Diseases
Cutaneous T-cell lymphoma
Sodium Salicylate
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Sezary Syndrome
Mycosis Fungoides

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Jejunal Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Ileal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008




Links to all studies - primarily for crawlers