Alisertib in Combination With Vorinostat in Treating Patients With Relapsed or Recurrent Hodgkin Lymphoma, B-Cell Non-Hodgkin Lymphoma, or Peripheral T-Cell Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01567709
Phase
PHASE1
Status
Completed

Conditions

  • Adult B Acute Lymphoblastic Leukemia
  • Adult T Acute Lymphoblastic Leukemia
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Hepatosplenic T-Cell Lymphoma
  • Intraocular Lymphoma
  • Lymphomatous Involvement of Non-Cutaneous Extranodal Site
  • Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Primary Cutaneous B-Cell Non-Hodgkin Lymphoma
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Immunoblastic Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Adult T-Cell Leukemia/Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Mycosis Fungoides and Sezary Syndrome
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Hairy Cell Leukemia
  • Small Intestinal Lymphoma
  • Splenic Marginal Zone Lymphoma
  • T-Cell Large Granular Lymphocyte Leukemia
  • Testicular Lymphoma
  • Waldenstrom Macroglobulinemia

Eligibility Criteria

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

Interventions

  • Alisertib — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Vorinostat — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and the best dose of alisertib when given together with vorinostat in treating patients with Hodgkin lymphoma, B-cell non-Hodgkin lymphoma, or peripheral T-cell lymphoma that has come back. Alisertib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Apr 16, 2012
Status verified
Apr 2018
Primary completion
Mar 29, 2018
Completion
Mar 29, 2018

Study Design

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

Arms

  • Experimental: Treatment (alisertib, vorinostat)
    Patients receive alisertib PO BID on days 1-7 or days 1-3 and 8-10, and vorinostat PO BID on days 1-14 or days 1-5 and 8-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

MTD of alisertib defined as the highest dose tested in which less than 33% of patients experienced dose-limiting toxicity (DLT) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.0 [ Time Frame: 21 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-0850-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAPenn State Milton S Hershey Medical Center· Hershey, PAUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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