This phase I trial studies the side effects and best dose of romidepsin when given together with gemcitabine hydrochloride, oxaliplatin, and dexamethasone in treating patients with lymphoma that has returned after previous treatment (relapsed) or does not respond to treatment (refractory) and is growing and spreading quickly (aggressive). Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, oxaliplatin, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving romidepsin with gemcitabine hydrochloride, oxaliplatin, and dexamethasone may be a better treatment for lymphoma.
Additional locations may be listed on ClinicalTrials.gov for NCT02181218.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of romidepsin when given in combination with gemcitabine (gemcitabine hydrochloride), oxaliplatin, and dexamethasone to patients with lymphoma.
SECONDARY OBJECTIVES:
I. To determine complete response (CR) rate, partial response (PR) rate, and overall response rates (ORR = CR + PR) of treatment of patients diagnosed with lymphoma with romidepsin in combination with gemcitabine hydrochloride, oxaliplatin, and dexamethasone (GemOxD).
II. To determine progression-free survival (PFS) and duration of response (DOR) of patients diagnosed with lymphoma treated with romidepsin in combination with GemOxD.
TERTIARY OBJECTIVES:
I. To determine whether the addition of romidepsin to GemOxD results in improved clinical benefit.
OUTLINE: This is a dose-escalation study of romidepsin.
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes and oxaliplatin IV over 2 hours on day 1 and dexamethasone orally (PO) on days 1-4. Patients also receive romidepsin IV over 4 hours on day 2. Patients with diffuse large B-cell lymphoma (DLBCL) may also receive rituximab IV on day 1 before gemcitabine hydrochloride administration. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 28 days and then every 3 months for up to 2 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorNeha Mehta-Shah