Clinical trial NCT00151281: Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
Official title: Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: relapsed mantle cell lymphoma
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Overall Survival and Progression Free Survival
timeFrame: 38 months
Secondary outcomes:
measure: Asses the Toxicity Profiles
timeFrame: 38 months
measure: Dynamic Levels of Plasma VEGF
timeFrame: 38 months
measure: The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment
timeFrame: baseline, every 2 months until Month 6, and every 6 months until disease progression
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: John P Leonard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruan J, Martin P, Coleman M, Furman RR, Cheung K, Faye A, Elstrom R, Lachs M, Hajjar KA, Leonard JP. Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma. Cancer. 2010 Jun 1;116(11):2655-64. doi: 10.1002/cncr.25055.