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Clinical Trials/NCT00669812
NCT00669812UnknownPhase 2

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

Cancer Research UK2 sites in 1 country60 target enrollmentStarted: February 1, 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Enrollment
60
Locations
2
Primary Endpoint
Survival at 1 year
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Survival at 1 year

Secondary Outcomes

  • Toxicity

Investigators

Sponsor Class
Other

Study Sites (2)

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