Everolimus, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Untreated Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT01334502
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    PO
  • cyclophosphamide — DRUG
    IV
  • doxorubicin hydrochloride — DRUG
    IV
  • everolimus — DRUG
    PO
  • prednisone — DRUG
    PO
  • vincristine sulfate — DRUG
    IV

Study Details

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer cells 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, 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 stopping them from dividing. Giving everolimus together with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and the best dose of everolimus when given together with rituximab and combination chemotherapy in treating patients with newly diagnosed untreated diffuse large B-cell lymphoma.

Key Dates

Start date
Mar 31, 2012
Status verified
Aug 2017
Primary completion
Feb 28, 2015
Completion
Aug 31, 2017

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: everolimus and RCHOP
    Patients registered to the study will receive an assigned dose of everolimus by mouth and RCHOP for a maximum of six cycles. Each cycle is a total of 21 days. RCHOP consists of 375 mg/m2 IV rituximab, 750 mg/m2 IV cyclophosphamide, 50 mg/m2 IV doxorubicin, 1.4 mg/m2 IV vincristine and 100 mg/m2 by mouth QD prednisone. The study includes a Phase I component to determine the maximum tolerated dose of everolimus and the second component determines the feasibility of therapy administered to lymphoma patients.

Primary Outcome Measure

MTD of everolimus in combination with R-CHOP [ Time Frame: Up to 15 months post registration to Phase I portion of the study ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic Cancer CenterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By research site
Mayo Clinic Cancer Center· Rochester, MN

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