Clinical Trials /

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

NCT00669812

Description:

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.

Related Conditions:
  • Enteropathy-Associated T-Cell Lymphoma
Recruiting Status:

Unknown status

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT00669812

Trial Eligibility

Document

Title

  • Brief Title: High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma
  • Official Title: A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas

Clinical Trial IDs

  • ORG STUDY ID: CDR0000593564
  • SECONDARY ID: CRUK-2005-003906-27
  • SECONDARY ID: CRUK-BRD/05/93
  • NCT ID: NCT00669812

Conditions

  • Lymphoma
  • Small Intestine Cancer

Interventions

DrugSynonymsArms
carmustine
cyclophosphamide
cytarabine
doxorubicin hydrochloride
epirubicin hydrochloride
etoposide
ifosfamide
melphalan
methotrexate
prednisolone
vincristine sulfate

Purpose

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 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.

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Survival at 1 year
Time Frame:
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Toxicity
Time Frame:
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Cancer Research UK

Trial Keywords

  • small intestine lymphoma
  • stage I adult T-cell leukemia/lymphoma
  • stage II adult T-cell leukemia/lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma

Last Updated

August 26, 2013