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Phase II Trial of RAD001 in Relapsed/Refractory Lymphoma

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors, Leukemia, Lymphoma, Lymphoproliferative Disorder, Small Intestine Cancer

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Trial Information

Phase II Trial of RAD001 in Relapsed/Refractory Lymphoma



- Assess the tumor response in patients with relapsed or refractory indolent non-Hodgkin
lymphoma (closed to accrual as of 8/18/08), aggressive non-Hodgkin's lymphoma (closed
to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular
lymphoma, or transformed lymphoma), or uncommon lymphoma (closed to accrual as of
9/2/08), including Hodgkin's lymphoma, treated with everolimus.

- Determine the toxicity of this drug in these patients.


- 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 2/7/08 except for diffuse large B cell
lymphoma, grade III follicular lymphoma, or transformed lymphoma] vs indolent lymphoma
[closed to accrual as of 8/18/08] vs uncommon lymphoma [closed to accrual as of 9/2/08]).

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.

Inclusion Criteria


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

- Aggressive lymphoma (closed to accrual as of 2/7/08 except for diffuse large B
cell lymphoma, grade III follicular lymphoma, or transformed lymphoma)

- 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 (closed to accrual as of 8/18/08)

- 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 9/2/08)

- 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


- 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

- 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

- No known HIV positivity


- 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

Type of Study:


Study Design:

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed response, defined as complete response (CR), CR unconfirmed, or partial response (PR)

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Thomas E. Witzig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Small Intestine Cancer
  • 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 non-Hodgkin lymphoma
  • primary central nervous system Hodgkin lymphoma
  • post-transplant lymphoproliferative disorder
  • recurrent adult diffuse small cleaved cell lymphoma
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorders
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905