Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma - Full Text View

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00310037

Purpose

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with an autologous stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib after combination chemotherapy, monoclonal antibody therapy, and an autologous stem cell transplant may kill any remaining cancer cells or keep the cancer from coming back.

PURPOSE: This randomized phase II trial is studying how well bortezomib works when given after combination chemotherapy, rituximab, and an autologous stem cell transplant in treating patients with mantle cell lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: bortezomib	Phase II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label
Official Title:	A Randomized Phase II Trial of Maintenance vs Consolidation Bortezomib Therapy Following Aggressive Chemo-Immunotherapy and Autologous Stem Cell Transplant for Previously Untreated Mantle Cell Lymphoma

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

Primary Outcome Measures:

Progression-free survival at 18 months [ Designated as safety issue: No ]

Estimated Enrollment:	98
Study Start Date:	June 2006
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I maintenance therapy: Active Comparator Patients receive bortezomib IV on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.	Drug: bortezomib Given IV
Arm II consolidation therapy: Experimental Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.	Drug: bortezomib Given IV

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed mantle cell lymphoma, meeting the following criteria:
- Stage I-IV disease
  - Patients with nodular histology must have stage III or IV disease
Co-expression of CD20 (or CD19) and CD5 AND lack of CD23 expression by immunophenotyping
At least 1 of the following confirmatory tests:
- Positive immunostaining for cyclin D1
- Presence of t(11;14) on cytogenetic analysis
- Molecular evidence of bcl-1/IgH rearrangement
Previously untreated disease OR ≤ 1 prior course of chemotherapy and/or rituximab
No mantle zone histology
No Waldenstrom's macroglobulinemia
No active CNS disease defined as symptomatic meningeal lymphoma
No known CNS parenchymal lymphoma

PATIENT CHARACTERISTICS:

LVEF ≥ 45% by MUGA or echocardiogram
Creatinine ≤ 2.0 mg/dL
Patients testing positive for hepatitis B surface antigen or hepatitis C antibody are eligible provided all of the following criteria are met:
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Fibrosis ≤ grade 2 fibrosis AND no cirrhosis by liver biopsy
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No known hypersensitivity to murine products
No medical condition requiring chronic use of oral corticosteroids
No known HIV positivity
No currently active second malignancy other than nonmelanoma skin cancer
- Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and are considered to have < 30% risk of relapse

PRIOR CONCURRENT THERAPY:

At least 2 weeks since prior major surgery
At least 3 weeks since prior chemotherapy
No prior radiotherapy for mantle cell lymphoma
No other concurrent hormonal therapy or chemotherapy except for the following:
- Corticosteroids for adrenal failure, diffuse alveolar hemorrhage, or carmustine pneumonitis
- Dexamethasone as an antiemetic or premedication for rituximab
- Hormones for nonlymphoma-related conditions (e.g., insulin for diabetes)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310037

Show 43 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Lawrence D. Kaplan, MD

UCSF Helen Diller Family Comprehensive Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	Cancer and Leukemia Group B ( Richard L. Schilsky )
Study ID Numbers:	CDR0000466167, CALGB-50403
Study First Received:	March 29, 2006
Last Updated:	May 2, 2009
ClinicalTrials.gov Identifier:	NCT00310037 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage I mantle cell lymphoma

stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lymphoma, Mantle-Cell
Bortezomib
Mantle Cell Lymphoma

Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Aggression
Lymphoma
Recurrence
Protease Inhibitors

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Lymphoma, Mantle-Cell
Bortezomib
Enzyme Inhibitors

Pharmacologic Actions
Protease Inhibitors
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009