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

Sponsored by:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00151281

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 II

MedlinePlus related topics: Lymphoma

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma

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

Contacts

Contact: Trish Glynn, RN

212-746-6738

Locations

United States, New York
Weill Medical College of Cornell University	Recruiting
New York, New York, United States, 10021
Contact: John P Leonard, MD 212-746-2932
Principal Investigator: John P Leonard, MD
Sub-Investigator: Jia Ruan, MD, PhD
Sub-Investigator: Shahin Rafii, PhD

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:

John P Leonard, MD

Weill Medical College of Cornell University

More Information

Responsible Party:	Weill Cornell Medical College ( John P. Leonard, MD )
Study ID Numbers:	0904-473
Study First Received:	September 6, 2005
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00151281
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

relapsed mantle cell lymphoma

Study placed in the following topic categories:

Prednisone
Immunoproliferative Disorders
Thalidomide
Rituximab
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Cyclophosphamide
Etoposide phosphate

Mantle cell lymphoma
Lymphatic Diseases
Procarbazine
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Etoposide

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Anti-Bacterial Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents
Neoplasms by Histologic Type

Immune System Diseases
Antineoplastic Agents, Hormonal
Growth Substances
Immunosuppressive Agents
Glucocorticoids
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Leprostatic Agents

ClinicalTrials.gov processed this record on January 16, 2009