Status:
COMPLETED
Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * 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 ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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)
- Central Nervous System (CNS) lymphoma
- Post-transplant lymphoproliferative disorder
- Mycosis fungoides/Sezary syndrome
- Hodgkin's lymphoma
- Primary effusion lymphoma
- Blastic Natural Killer(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 Immunoglobulin M(IgM) monoclonal protein \> 1,000 mg/dL
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group(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
- aspartate aminotransferase(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
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2019
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00436618
Start Date
August 1 2005
End Date
October 9 2019
Last Update
October 22 2019
Active Locations (3)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
3
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905