Trial record 7 of 13 for:    Open Studies | "Duodenal Neoplasms"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00669812
First received: April 30, 2008
Last updated: August 23, 2013
Last verified: November 2008
  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.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
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
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669812

Locations
United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Contact: Anne Lennard    44-191-282-4743    a.l.lennard@ncl.ac.uk   
Sponsors and Collaborators
Cancer Research UK
Investigators
Principal Investigator: Anne Lennard Sir James Spence Institute of Child Health at Royal Victoria Infirmary
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00669812     History of Changes
Other Study ID Numbers: CDR0000593564, CRUK-2005-003906-27, CRUK-BRD/05/93
Study First Received: April 30, 2008
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Duodenal Neoplasms
Lymphoma
Lymphoma, T-Cell
Ileal Neoplasms
Jejunal Neoplasms
Intestinal Neoplasms
Enteropathy-Associated T-Cell Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Ileal Diseases
Jejunal Diseases
Carmustine
Cyclophosphamide
Ifosfamide
Isophosphamide mustard
Melphalan
Liposomal doxorubicin
Cytarabine

ClinicalTrials.gov processed this record on August 28, 2014