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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00553644 |
RATIONALE: Bortezomib and lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with lenalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with lenalidomide works in treating patients with relapsed or refractory mantle cell lymphoma.
Condition | Intervention | Phase |
Lymphoma |
Drug: bortezomib Drug: lenalidomide |
Phase II |
MedlinePlus related topics: | Cancer Lymphoma |
ChemIDplus related topics: | Bortezomib Lenalidomide CC 5013 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide (Revlimid ™, CC-5013) (NSC #703813) for Relapsed/Refractory Mantle Cell Lymphoma |
Estimated Enrollment: | 54 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive induction therapy comprising bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib IV on days 1 and 8 and oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma meeting the following criteria:
Diagnosis confirmed by initial biopsy or at time of relapse
No bone marrow biopsy as sole means of diagnosis
Measurable disease, defined as any tumor mass > 1 cm by physical examination, CT scan, MRI, or conventional radiograph
No nonmeasurable disease only, including any of the following:
Received prior therapy with at least 1 regimen, which may have been single- or multi-agent, and consisted of traditional cytotoxic and/or biologic agents
Must have progressive or refractory disease following initial regimen
PATIENT CHARACTERISTICS:
Patients with HIV infection are eligible, provided they meet the following criteria:
No deep vein thrombosis (DVT) and/or pulmonary embolism (PE) within the past 3 months
PRIOR CONCURRENT THERAPY:
Prior autologous stem cell transplantation (SCT) allowed
More than 2 weeks since prior corticosteroids, except maintenance therapy for a non-malignant disease
Show 49 Study Locations |
Cancer and Leukemia Group B |
National Cancer Institute (NCI) |
Study Chair: | Vicki A. Morrison, MD | Veterans Affairs Medical Center - Minneapolis |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000573827, CALGB-50501 |
First Received: | November 2, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00553644 |
Health Authority: | Unspecified |
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