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

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ClinicalTrials.gov Identifier: NCT00669812
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 1, 2008
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE April 30, 2008
First Posted Date  ICMJE May 1, 2008
Last Update Posted Date August 26, 2013
Study Start Date  ICMJE February 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2008)
Survival at 1 year
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00669812 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2008)
Toxicity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma
  • Small Intestine Cancer
Intervention  ICMJE
  • Drug: carmustine
  • Drug: cyclophosphamide
  • Drug: cytarabine
  • Drug: doxorubicin hydrochloride
  • Drug: epirubicin hydrochloride
  • Drug: etoposide
  • Drug: ifosfamide
  • Drug: melphalan
  • Drug: methotrexate
  • Drug: prednisolone
  • Drug: vincristine sulfate
  • Procedure: autologous hematopoietic stem cell transplantation
  • Procedure: biopsy
  • Procedure: peripheral blood stem cell transplantation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 30, 2008)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00669812
Other Study ID Numbers  ICMJE CDR0000593564
CRUK-2005-003906-27
CRUK-BRD/05/93
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Cancer Research UK
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne Lennard Sir James Spence Institute of Child Health at Royal Victoria Infirmary
PRS Account National Cancer Institute (NCI)
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP