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

History of Changes

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:

Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma.
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.
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:

MedlinePlus related topics: Lymphoma Steroids

Drug Information available for: Cyclophosphamide Thalidomide Prednisone Procarbazine hydrochloride Procarbazine Etoposide Etoposide phosphate Rituximab

U.S. FDA Resources

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:

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

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, Mantle-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Thalidomide
Rituximab
Etoposide
Prednisone
Procarbazine

Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013

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