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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Other	CDR0000528926 ECOG-E1405, NCT00433537

Trial Description

Summary

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

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib works in treating patients with untreated mantle cell lymphoma.

Further Study Information

OBJECTIVES:

Primary

• Determine the complete response rate in patients with untreated mantle cell lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, bortezomib, and dexamethasone (VcR-CVAD).

Secondary

• Evaluate the overall response rate in patients treated with this regimen.

• Evaluate the progression-free survival (PFS) and overall survival (OS) of patients treated with maintenance rituximab after VcR-CVAD induction therapy.

• Evaluate the PFS and OS of patients who undergo autologous stem cell transplantation after VcR-CVAD induction therapy.

• Evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

• Induction therapy (VcR-CVAD): Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

• Maintenance therapy: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed mantle cell lymphoma meeting ≥ 1 of the following criteria:

• Nuclear cyclin D1+ by immunohistochemistry

• t(11;14) by fluorescent in situ hybridization (FISH), polymerase chain reaction, or conventional karyotyping

• Measurable disease by CT scan

• No known CNS involvement

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute neutrophil count > 1,500/mm^3 (unless low counts are due to marrow involvement or splenomegaly)

• Platelet count > 100,000/mm^3 (unless low counts are due to marrow involvement or splenomegaly)

• Creatinine < 2.0 mg/dL

• Bilirubin < 2 mg/dL (≤ 3.0 mg/dL if due to Gilbert's disease or liver involvement by lymphoma)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• LVEF > 45% within the past 90 days (for patients > 45 years of age)

• No known HIV positivity

• No baseline peripheral neuropathy ≥ grade 2

• No known hypersensitivity to boron or mannitol

• No prior malignancy unless ≥ 1 of the following conditions are met:

• Malignancy was in situ

• Malignancy was treated surgically or with local external radiotherapy with curative intent and the patient has been disease free for > 3 years

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy, immunotherapy, or radiotherapy for mantle cell lymphoma

• Brief course (< 14 days) of steroid use for symptom relief or other indications allowed

• At least 3 months since prior adjuvant hormonal therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Brad S. Kahl

Study Chair

Mitchell Reed Smith

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00433537
Information obtained from ClinicalTrials.gov on January 28, 2010

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