High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma
Recruitment status was Recruiting
Tracking Information | |||||
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First Received Date ICMJE | April 30, 2008 | ||||
Last Updated Date | February 13, 2009 | ||||
Start Date ICMJE | February 2008 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Survival at 1 year [ Designated as safety issue: No ] | ||||
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 |
Toxicity [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study
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.
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 60 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | |||||
Location Countries ICMJE | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00669812 | ||||
Other Study ID Numbers ICMJE | CDR0000593564, CRUK-2005-003906-27, CRUK-BRD/05/93 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Cancer Research UK | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | 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 |