Status:
UNKNOWN
High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma
Lead Sponsor:
Cancer Research UK
Conditions:
Lymphoma
Small Intestine Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 collec...
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 st...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00669812
Start Date
February 1 2008
Last Update
August 26 2013
Active Locations (1)
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1
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom, NE1 4LP