A Phase 1 interventional study of alemtuzumab and cyclophosphamide in Lymphoma and Small Intestine Cancer, sponsored by Cancer Research UK. Status unknown at 5 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-26.
Sponsored by Cancer Research UK · Phase 1, Interventional, and Treatment
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose escalation of alemtuzumab study.
Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive alemtuzumab subcutaneously (SC) 1-3 times a week for up to 6 doses per course. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline, periodically during study treatment, and after completion of study therapy for pharmacokinetics and other correlative studies to monitor cellular immunity. Blood samples are examined by polymerase chain reaction to detect cytomegalovirus antigen and to monitor Epstein-Barr virus copy number. Samples are also analyzed by flow cytometry to quantify circulating B- and T-cells, NK-cells, monocytes, and dendritic-cells.
After completion of study therapy, patients are followed every 3 months for the first year, every 6 months for the second year, and then yearly thereafter.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Cancer Research UK is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of peripheral T-cell lymphoma (PTCL), including the following subtypes:
PATIENT CHARACTERISTICS:
No positive serology or non-consenting to test for any of the following:
PRIOR CONCURRENT THERAPY:
Immediate toxicity (incidence of infusion-related reactions)
Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)
Incidence of infection (number of days with fever ≥ 38 degrees C, days of intravenous antibiotics, number of inpatient days, number of episodes of cytomegalovirus reactivation)
Disease response (remission rate [complete response and partial response])
Disease outcome (time to progression and overall survival at 2 years from completion of therapy)
Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L)
Relative dose intensity
Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment
Epstein-Barr virus copy number (measured retrospectively)
This study is status unknown, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
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