This research is being done because it is not yet known what dose of romidepsin in combination with gemcitabine, dexamethasone, and cisplatin (GDP) can be given safely to patients with peripheral T-cell lymphoma, nor what type and severity of side effects will result from the combination of these treatments. This research is also being done because it is not clear if the addition of the new drug romidepsin to treatment with GDP can offer better results and longer survival.
The purpose of this study is to find the highest dose of romidepsin that can safely be given in combination with gemcitabine, dexamethasone, and cisplatin (GDP) without causing very severe side effects that are not tolerable. This is done by starting at a dose lower than the one that does not cause side effects in animals. Patients are given romidepsin and GDP and watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more patients are asked to join the study and are given a higher dose of romidepsin (with GDP). Patients joining the study later on will get higher doses of romidepsin (with GDP) than patients who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Group 1 = 1000 mg/m2 D1, D8. Subsequent dose levels according to toxicity = 600-1000 mg/m2 D1, D15.
40 mg D1 - D4
75 mg/m2 D1
Dose Level 0 - 6 mg/m2 D1, D8. Subsequent dose levels according to toxicity 6-14 mg/m2 D1, D15.
Tom Baker Cancer Centre
Calgary, Alberta, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Regional Health Authority B, Zone 2
Saint John, New Brunswick, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Maximum tolerated dose of combined romidepsin, gemcitabine, dexamethasone and cisplatin.
Combination of GDP with romidepsin at the maximum tolerated doses of these agents will identify the combination regimen for comparison in the subsequent randomized phase II trial; if romidepsin appears to improve the activity of GDP, then this will move forward to a formal phase III comparison to CHOP. Primary end points are toxicity, the maximum administered dose and the recommended phase II dose.
Time frame: 48 months
Number of patients with adverse events
Adverse events by grade, dose level and total incidence; vital signs will be summarized and DLTs reported separately
Time frame: 48 months
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