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Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Weill Medical College of Cornell University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00151281
First received: September 6, 2005
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

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

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • effect of drug combination on mantle cell lymphoma [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: November 2004
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide

    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.
    • Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.
    • Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.

    Maintenance phase (month 4-12)

    • Daily low dose thalidomide (50-100 mg/d)
    • PEPC QOD or fractionated weekly basis.
    • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.

    Post-Month 12 Maintenance phase (post-month 12 until disease progression)

    • Daily low dose thalidomide (50-100mg/d)
    • PEPC QOD or fractionated weekly basis
    • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151281

Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: John P Leonard, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: John P. Leonard, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00151281     History of Changes
Other Study ID Numbers: 047080073974
Study First Received: September 6, 2005
Last Updated: June 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
relapsed mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Etoposide
Prednisone
Procarbazine
Rituximab
Thalidomide
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Growth Inhibitors
Growth Substances

ClinicalTrials.gov processed this record on November 20, 2014