CompletedPhase 2

Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma

Canada95 participantsStarted 2007-05-01

Plain-language summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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 together with combination chemotherapy and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with combination chemotherapy and rituximab works when given as first-line therapy in treating patients with stage III or stage IV follicular non-Hodgkin's lymphoma.

Who can participate

Age range18 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically confirmed follicular non-Hodgkin's lymphoma meeting the following criteria: * Stage III or IV disease * Grade 1, 2, or 3 disease requiring systemic first-line treatment * No transformation to diffuse large cell lymphoma * At least 1 bidimensionally measurable lesion meeting 1 of the following criteria: * Lymph nodes \> 1.5 cm x 1.0 cm by physical exam or CT scan * Other non-nodal lesion ≥ 1.0 cm x 1.0 cm by MRI or CT scan OR ≥ 1.0 cm x 1.0 cm (e.g., skin lesions or nodules) by physical exam * Must have a medical indication for treatment, as indicated by 1 of the following: * Presence of constitutional symptoms that are attributed to lymphoma (e.g., B symptoms, including night sweats, fever, weight loss, fatigue, or pain) * Lymphadenopathy that requires treatment based on presence of associated symptoms, potential threat to organ function (e.g., ureteric compromise from retroperitoneal disease), or degree of enlargement (i.e., \> 5 cm) * Impairment of normal organ function (e.g., impaired hematopoiesis due to marrow involvement by lymphoma or from splenomegaly and hypersplenism) * Immune-related complications of lymphoma that require therapy * Rate of disease progression for which observation is deemed inappropriate * No history of any other lymphoproliferative disorder or evidence of transformation to an aggressive histology lymphoma * No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: * ECOG perfo…

What they're measuring

Complete response rate

Timeframe: 5 years

Incidence of severe grade 3 or 4 neurotoxicity or neuropathic pain during the first 4 courses of treatment

Timeframe: 5 years

Trial details

NCT IDNCT00428142

SponsorNCIC Clinical Trials Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2011-04