Back to resultsPhase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PEPC
Thalidomide
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring relapsed mantle cell lymphoma
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
Sites / Locations
- Weill Medical College of Cornell University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Treatment Arm
Arm Description
Outcomes
Primary Outcome Measures
Overall Survival and Progression Free Survival
measured by overall Response Rate (ORR), which includes Complete response and partial response.
Secondary Outcome Measures
Asses the Toxicity Profiles
Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
Dynamic Levels of Plasma VEGF
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
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.
Full Information
NCT ID
NCT00151281
First Posted
September 6, 2005
Last Updated
June 26, 2018
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT00151281
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 7, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
relapsed mantle cell lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Treatment Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PEPC
Other Intervention Name(s)
Prednisone, Cyclophosphamide, Etoposide, Procarbazine
Intervention Description
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.
Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis.
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
• PEPC QOD or fractionated weekly basis
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
Induction phase (month 1-3)
• Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.
Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d)
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
• Daily low dose thalidomide (50-100mg/d)
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Induction phase (month 1-3)
• Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.
Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.
Post-Month 12 Maintenance phase (post-month 12 until disease progression)
• Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months
Primary Outcome Measure Information:
Title
Overall Survival and Progression Free Survival
Description
measured by overall Response Rate (ORR), which includes Complete response and partial response.
Time Frame
38 months
Secondary Outcome Measure Information:
Title
Asses the Toxicity Profiles
Description
Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
Time Frame
38 months
Title
Dynamic Levels of Plasma VEGF
Description
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.
Time Frame
38 months
Title
The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment
Description
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.
Time Frame
baseline, every 2 months until Month 6, and every 6 months until disease progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Leonard, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20235190
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.
Results Reference
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Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
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