Combination Chemotherapy With or Without Bortezomib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisolone, 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 combination chemotherapy together with bortezomib may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without bortezomib in treating mantle cell lymphoma.

PURPOSE: This randomized phase II trial is studying combination chemotherapy and bortezomib to see how well they work compared with combination chemotherapy alone in treating patients with relapsed or refractory mantle cell lymphoma. Combination chemotherapy alone (Arm I) has been discontinued April 2012 on recommendation of the DMC.

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

Details

• Lead Sponsor: Plymouth Hospitals NHS Trust; University Hospital Plymouth NHS Trust
• Treatments: Bortezomib; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of mantle cell lymphoma (MCL)

• Expression of cyclin D1 or evidence of t(11;14) translocation by cytogenetics, FISH, or polymerase chain reaction

• Refractory to or relapsed or progressed after first line antineoplastic therapy

• Measurable disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2

• ANC ≥ 1,000/mm³ (not related to lymphoma)

• Platelet count ≥ 30,000/mm³

• AST and ALT ≤ 3 times upper limit of normal (ULN)

• Total bilirubin ≤ 2 times ULN

• Creatinine clearance ≥ 20 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

Exclusion criteria:

• Known serological positivity for HBV, HCV, or HIV

• History of allergic reaction attributable to compounds containing boron or mannitol

• Diagnosed or treated for a malignancy other than MCL within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or any in situ malignancy

• Active systemic infection requiring treatment

• Serious medical or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• Toxic effects of prior therapy or surgery must be resolved to ≤ grade 2

• Prior splenectomy or localized radiotherapy allowed

• Any prior chemotherapy regimen allowed

• Chemotherapy may have been given in combination with rituximab

• Concurrent enrollment in a nontreatment study allowed, provided it does not interfere with participation in this study

Exclusion criteria:

• Prior bortezomib

• Antineoplastic therapy within the past 3 weeks

• Nitrosoureas within the past 6 weeks

• Rituximab, alemtuzumab (Campath®), or other unconjugated therapeutic antibody within the past 4 weeks

• Radiotherapy within the past 3 weeks

• Major surgery within the past 2 weeks

• Concurrent investigational agents