Vorinostat + Rituximab + Chemotherapy for Diffuse Large B-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+204 other locations

Overseen byDaniel O Persky

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab and combination chemotherapy and to see how well it works in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large B-cell lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell 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 cell-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with rituximab and combination chemotherapy may kill more cancer cells.

Research Team

Daniel O Persky

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with newly diagnosed stage II (bulky), III, or IV diffuse large B-cell lymphoma. Participants must have a certain level of physical fitness (Zubrod performance status 0-2) and adequate organ function as shown by blood tests. They should not be HIV positive, pregnant, or breastfeeding and must agree to use effective contraception. Prior cancer treatments are disallowed except for specific minor cases.

Inclusion Criteria

I have not had chemotherapy, radiation, or antibody therapy for lymphoma.

I can take care of myself and am up and about more than 50% of my waking hours.

I do not have HIV.

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Treatment Details

Interventions

Cyclophosphamide (Alkylating Agent)
Doxorubicin Hydrochloride (Topoisomerase II Inhibitor)
Prednisone (Corticosteroid)
Rituximab (Monoclonal Antibody)
Vincristine Sulfate (Vinca Alkaloid)
Vorinostat (Histone Deacetylase Inhibitor)

Trial OverviewThe study is testing the combination of vorinostat with rituximab and chemotherapy drugs like cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone in treating advanced diffuse large B-cell lymphoma. It aims to find the best dose of vorinostat that's effective while monitoring how well this regimen works against cancer cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (combination chemotherapy)Experimental Treatment7 Interventions

Patients receive vorinostat PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Cyclophosphamide is already approved in Canada, Japan for the following indications: