High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma

August 23, 2013 updated by: Cancer Research UK

A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas

RATIONALE: Giving chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This phase II trial is studying high-dose chemotherapy given together with peripheral blood stem cell transplant in treating patients with intestinal T-cell lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To assess the efficacy and toxicity of intensive high-dose chemotherapy (alternating I'VE regimen and intermediate-dose methotrexate) followed by autologous peripheral blood stem cell transplantation for treatment of patients with intestinal T-cell lymphoma.

Secondary

  • To assess the toxicity of the regimen in a large population of these patients.
  • To provide a coordinated approach to the treatment of these patients.
  • To register patients unfit for the protocol chemotherapy into the pathological part of the study.

OUTLINE: This is a multicenter study

  • Chemotherapy: Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1. Patients also receive oral prednisolone on days 1-5.

After recovering from CHOP chemotherapy, patients receive I'VE chemotherapy comprising epirubicin hydrochloride IV on day 1 and etoposide IV over 2 hours and ifosfamide IV continuously on days 21-23. Patients also receive methotrexate IV over 24 hours on day 21. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

  • Consolidation therapy: On day 77, stem cells are collected from patients if the marrow is clear of disease. After completion of chemotherapy, patients in complete remission receive carmustine IV on day 105, cytarabine IV and etoposide IV on days 106-109, and melphalan IV on day 110. These patients undergo autologous peripheral blood stem cell transplantation on day 112.

Prior to study treatment, patients undergo a biopsy of the gut to confirm diagnosis and a blood sample is taken. Both blood and tissue samples may be used for further studies.

After recovery from treatment, patients are followed monthly for 4 months, then bimonthly for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
        • Recruiting
        • Sir James Spence Institute of Child Health at Royal Victoria Infirmary
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Newly confirmed diagnosis of intestinal T-cell lymphoma/ enteropathy-type T-cell lymphoma according to the following WHO classifications:

    • Usual phenotype CD3-, CD7-positive; CD5-, CD4-, CD8-negative; or CD30-positive
  • Complete surgical resection allowed

PATIENT CHARACTERISTICS:

  • Unsupported neutrophils ≥ 1,500/mm^3 unless attributed to lymphomatous bone marrow infiltration
  • Unsupported platelets ≥ 100,000/mm^3 unless attributed to lymphomatous bone marrow infiltration
  • Creatinine clearance ≥ 50 mL/min
  • Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.5 times ULN
  • Left ventricular ejection fraction ≥ 50%
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
  • Patients with any serious concomitant medical or psychiatric condition that would preclude them tolerating the planned treatment should be entered into the registration study only
  • No known hepatitis B, hepatitis C, or HIV positivity
  • No active uncontrolled cardiovascular disease
  • No abnormal EKG if there is a previous history of cardiac problems
  • No other severe impairment of cardiac function
  • No active malignancy within the past 5 years except cervical intraepithelial neoplasia or localized skin cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior diagnostic or emergency surgical procedures allowed
  • More than 5 years since prior treatment for malignancy
  • No prior chemotherapy or radiotherapy for treatment of lymphoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival at 1 year

Secondary Outcome Measures

Outcome Measure
Toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research UK

Investigators

  • Principal Investigator: Anne Lennard, Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

April 30, 2008

First Posted (Estimate)

May 1, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000593564
  • CRUK-2005-003906-27
  • CRUK-BRD/05/93

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe