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

Phase 2

Completed

Conditions: Non-Hodgkin's Lymphoma

Interventions: Drug: PEPC
Drug: Thalidomide
Drug: Rituximab

Registration Number: NCT00151281

Lead Sponsor: Weill Medical College of Cornell University

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Treatment Arm	PEPC	-
Study Treatment Arm	Rituximab	-
Study Treatment Arm	Thalidomide	-

Primary Outcome Measures

Name	Time	Method
Overall Survival and Progression Free Survival	38 months	measured by overall Response Rate (ORR), which includes Complete response and partial response.

Secondary Outcome Measures

Name	Time	Method
Asses the Toxicity Profiles	38 months	Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
Dynamic Levels of Plasma VEGF	38 months	Stromal angiogenesis was assessed using blood vascular and perivascular markers, including VEGFR-1, VEGFR-2, CD34, and a-SMA, as well as lymphatic vascular markers ofVEGFR-3, podoplanin, and Lyve-1.
The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment	baseline, every 2 months until Month 6, and every 6 months until disease progression	QoL assessments were obtained with version 3 of the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). Users of the FACT-G are able to generate an overall score and four subscale scores with ranges and distributions that are sample-specific. All questions in the FACT-G use a 5-point rating scale (0 = Not at all to 4 = Very much) A higher number indicates a better Quality of Life, and has a possible range of 0-108 points. ANOVA was used to compare the difference in the means of total score among the different time points (baseline, every 2M until 6M, and every 6M until PD). The mean of the total FACT-G scores at baseline and mean of total score at all timepoints (using ANOVA) are reported below.