Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: PEPC; Thalidomide; Rituximab
Intervention description: Induction phase (month 1-3)
• PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.
Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis.
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
• PEPC QOD or fractionated weekly basis; Induction phase (month 1-3)
• Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.
Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d)
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
• Daily low dose thalidomide (50-100mg/d); Induction phase (month 1-3)
• Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.
Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
• Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months
Intervention MeSH terms: Thalidomide; Prednisone; Cyclophosphamide; Rituximab; Etoposide; Procarbazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: relapsed mantle cell lymphoma

Summary:

      Primary Objective:

      Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide,
      and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle
      cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be
      assessed.

      Secondary Objectives:

        1. Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell
           lymphoma.

        2. Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma
           during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated
           with clinical response to RT-PEPC therapy.

        3. Assess the quality of life of patients receiving RT-PEPC treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with
             characteristic immunophenotypic profiles: CD5(+),CD23(-), CD19(+) or CD20(+), cyclin
             D1(+), and CD10(-)

          -  Patient has persistent / recurrent disease after standard chemotherapy

          -  Patient has not received either standard or investigational drugs within the last 3
             weeks

          -  Available frozen tumor tissue obtained since completion of last prior therapy
             (rebiopsy if needed)

          -  Patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension

          -  Age > 18 years

          -  Absolute granulocyte count > 1000 cells/mm3

          -  Platelet count > 50,000 cells/mm3

          -  Creatinine < 2.0 x ULN

          -  Total bilirubin < 2.0 x ULN

          -  Patient has KPS > 50%

          -  Patient agrees to use birth control if of reproductive potential

        Exclusion Criteria:

          -  Known central nervous system (CNS) involvement by lymphoma

          -  Known HIV disease

          -  Known peripheral neuropathy > grade 2

          -  Patient is pregnant or nursing

          -  Patient has had major surgery within the last 3 weeks

          -  Patient is receiving other investigational drugs