Rituximab, Bortezomib, Doxorubicin, Dexamethasone, and Chlorambucil as First-Line Therapy in Treating Older Patients With Stage II, Stage III, or Stage IV Mantle Cell Lymphoma - Full Text View

Sponsored by:	Groupe Ouest Est d'etude des Leucemies et Autres Maladies du Sang
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00740415

Purpose

RATIONALE: 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, dexamethasone, and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy together with rituximab and bortezomib may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with bortezomib, doxorubicin, dexamethasone, and chlorambucil works as first-line therapy in treating older patients with stage II, stage III, or stage IV mantle cell lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: bortezomib Drug: chlorambucil Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: rituximab	Phase II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Rituximab Bortezomib Chlorambucil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	First-Line Treatment of Mantle Cell Lymphoma of Patients Aged 65 to 80 Years. Evaluate the Efficacy, Toxicity, and Molecular Prognostic Factors of a Proteosome Inhibitor (PS341-Velcade®) in Association With Chemotherapy and Immunotherapy With Rituximab (Schema RiPAD + C)

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

Primary Outcome Measures:

Overall response rate after 4 courses of therapy [ Designated as safety issue: No ]

Estimated Enrollment:	39
Study Start Date:	June 2007
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Evaluate the efficacy of rituximab, bortezomib, doxorubicin hydrochloride, dexamethasone, and chlorambucil as first-line therapy in patients with stage II-IV mantle cell lymphoma.

Secondary

Determine the complete response rate in these patients.
Determine the efficacy, in terms of complete and overall response, by F18 fludeoxyglucose scan.
Determine overall, disease-free, and event-free survival of these patients.
Assess tolerability of this regimen in these patients.
Evaluate the impact of factors, described in previous protocols, on response to therapy and survival.
Assess the impact of residual disease in cerebrospinal fluid on survival.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1 (days 1 and 8 of the first course only); bortezomib IV on days 1, 4, 8, and 11; doxorubicin hydrochloride IV continuously over 24 hours on days 1-4; dexamethasone IV on days 1-4; and oral chlorambucil on days 20-29. Treatment repeats every 5 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve at least 50% response receive 2 additional courses of therapy.

Eligibility

Ages Eligible for Study:	65 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of mantle cell lymphoma
- Stage II-IV disease
No neuromeningeal disease

PATIENT CHARACTERISTICS:

WHO performance status 0-2
No prior cancer except for carcinoma in situ of the cervix or basal cell skin cancer
LVEF > 50%
HIV-negative
Hepatitis B- and C-negative
No hepatocellular, renal, or bone marrow insufficiency unrelated to lymphoma

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740415

Locations

France
CHU de Grenoble - Hopital Michallon	Recruiting
Grenoble, France, 38043
Contact: Contact Person 33-4-7676-5028

Sponsors and Collaborators

Groupe Ouest Est d'etude des Leucemies et Autres Maladies du Sang

Investigators

Study Chair:

Remy Gressin, MD

CHU de Grenoble - Hopital de la Tronche

More Information

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

Study ID Numbers:	CDR0000589544, GOELAMS-MANTEAU-2006-SA, INCA-RECF0475
Study First Received:	August 22, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00740415
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Rituximab
Lymphoma, Mantle-Cell
Chlorambucil
Bortezomib
Mantle cell lymphoma

Doxorubicin
Lymphatic Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Alkylating Agents
Neoplasms by Histologic Type
Immune System Diseases

Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Enzyme Inhibitors
Glucocorticoids
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009