Bortezomib in Treating Patients With Mantle Cell Lymphoma

• Status: Completed
• Trial end date: 2009-12-21
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Bortezomib

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma

• No refractory disease defined as progression while on chemotherapy or within 1 month after completion of chemotherapy

• At least 1 bidimensionally measurable disease site*

• Lymph nodes at least 1.5 cm by 1.5 cm by spiral CT scan OR

• Non-nodal lesions (e.g., skin lesion or nodules) at least 1 cm by 1 cm by MRI, CT scan, or physical exam NOTE: *Bone lesions are not considered bidimensionally measurable disease

• No pre-existing ascites or pleural effusion

• No known CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 75,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST or ALT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• LVEF at least 45% by echocardiogram or MUGA

Pulmonary

• No pre-existing shortness of breath greater than grade 1

Other:

• No uncontrolled bacterial, fungal, or viral infections

• No pre-existing edema greater than grade 1

• No pre-existing neuropathy greater than grade 1

• No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix

• No other serious illness or medical condition that would preclude study compliance

• No geographical conditions that would preclude study compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Chemotherapy

• Prior rituximab allowed

• No prior radioactive monoclonal antibody therapy

Chemotherapy:

• See Disease Characteristics

• No prior high-dose chemotherapy with stem cell transplantation

• No more than 2 prior systemic chemotherapy regimens

• Same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens

• No prior flavopiridol

• At least 6 weeks since prior chemotherapy

• No concurrent cytotoxic chemotherapy

Endocrine therapy:

• No concurrent corticosteroids

Radiotherapy:

• No prior radiotherapy to 25% or more of functioning bone marrow

• At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered

• No concurrent radiotherapy to the sole site of measurable disease

Surgery:

• At least 2 weeks since prior major surgery

Other:

• No prior investigational therapy

• No other concurrent anticancer therapy

• No other concurrent investigational anticancer therapy