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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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
    Sponsor: Cancer Research UK

    Current Primary Outcome: Survival at 1 year

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Toxicity

    Original Secondary Outcome: Same as current

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: April 30, 2008
    Date Started: February 2008
    Date Completion:
    Last Updated: August 23, 2013
    Last Verified: November 2008