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Completed

NCT Number: NCT00151281

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

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

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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Weill Medical College of Cornell University

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEPC

Drug

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

Other names: Prednisone, Cyclophosphamide, Etoposide, Procarbazine

thalidomide

Drug

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)

Rituximab

Drug

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 outcomes

  1. Overall Survival and Progression Free Survival

    Time frame: 38 months

    measured by overall Response Rate (ORR), which includes Complete response and partial response.

Secondary outcomes

  1. Asses the Toxicity Profiles

    Time frame: 38 months

    Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.

  2. Dynamic Levels of Plasma VEGF

    Time frame: 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.

  3. The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma

Important dates

Study start
2004
Primary completion
2009
Study completion
2011
First posted
Sep 8, 2005
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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