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

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Macroglobulinemia Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström’s Macroglobulinaemia An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia Simvastatin in Waldenstrom’s Macroglobulinemia Ibrutinib (PCI-32765) in Waldenstrom’s Macroglobulinemia Carfilzomib, Rituximab and Dexamethasone in Waldenstrom’s Macroglobulinemia Thalidomide and Rituximab in Waldenstrom’s Macroglobulinemia Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

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

Official Title

Phase I Study of the Aurora Kinase a Inhibitor MLN8237 in Combination With the Histone Deacetylase Inhibitor Vorinostat in Lymphoid Malignancies

Brief Summary

      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.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the maximum-tolerated dose (MTD) of MLN8237 (alisertib) when given in
      combination with vorinostat and to select a dose and schedule for further testing
      (recommended Phase 2 dose: RP2D) in patients with lymphoid malignancies.

      II. To describe the toxicities of MLN8237 when given in combination with vorinostat on a
      21-day schedule.

      III. To determine any clinical responses with MLN8237 in combination with vorinostat.

      IV. To compare the plasma pharmacokinetics of MLN8237 when given alone and in combination
      with vorinostat.

      V. To perform immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH)
      analysis to determine aurora kinase A (AURKA) expression in archival formalin-fixed
      paraffin-embedded sections from the most recent available tumor specimens of patients.

      VI. To perform correlative studies for apoptosis and proliferation on bone marrow and lymph
      node specimens, where available, obtained from patients in the expanded cohort at RP2D.

      OUTLINE: This is a dose-escalation study of alisertib.

      Patients receive alisertib orally (PO) twice daily (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.

      After completion of study treatment, patients are followed up for at least 30 days.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Incidence of toxicities produced by alisertib in combination with vorinostat assessed by the NCI CTCAE version 4.0

Condition

Adult B Acute Lymphoblastic Leukemia

Intervention

Alisertib

Study Arms / Comparison Groups

 Treatment (alisertib, vorinostat)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

34

Start Date

April 16, 2012

Completion Date

March 29, 2018

Primary Completion Date

March 29, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have a histologically or cytologically confirmed lymphoid malignancy
             (like Hodgkin lymphoma or one of the mature B- or T-cell non-Hodgkin lymphomas as
             classified by World Health Organization [WHO]) for which standard curative or
             palliative measures do not exist or are no longer effective

          -  Patients must have measurable disease in two dimensions and >= 2 cm is acceptable (or
             1.5 cm if 0.5 slices are used, as in spiral computed tomography [CT] scans); lesions
             that are considered intrinsically non-measurable include the following:

               -  Bone lesions

               -  Leptomeningeal disease

               -  Ascites

               -  Pleural/pericardial effusion

               -  Inflammatory breast disease

               -  Lymphangitis cutis/pulmonis

               -  Abdominal masses that are not confirmed and followed by imaging techniques

               -  Cystic lesions

               -  Lesions that are situated in a previously irradiated area

          -  Patients must have had at least 1 prior systemic chemotherapy (not just steroids or
             local radiation); last chemotherapy or radiation must be at least 4 weeks prior to
             enrollment on this study; patients who decline other potentially curative therapy may
             be eligible; prior radiation therapy must not have been to more than 25% of the bone
             marrow; whole pelvic radiation is considered to be over 25%

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

          -  Life expectancy of greater than 12 weeks

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total/direct bilirubin < 1.5 X institutional upper limit of normal; patients with
             elevation of indirect (unconjugated) bilirubin alone, as in Gilbert's syndrome, are
             eligible

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             < 2.5 X institutional upper limit of normal

          -  Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Prior allogeneic stem cell transplant patients will be allowed to enroll if they are
             past day +100 of transplant, have no active graft-versus-host-disease, are not on any
             immunosuppressants and have been off immunosuppressants for at least 4 weeks; prior
             autologous stem cell transplant patients will also be allowed to enter this study if
             they are past their day +100 of transplant

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry, for
             the duration of study participation, and 4 months after completion of MLN8237
             administration; should a woman become pregnant or suspect she is pregnant while she or
             her partner is participating in this study, she should inform her treating physician
             immediately; men treated or enrolled on this protocol must also agree to use adequate
             contraception prior to the study, for the duration of study participation, and 4
             months after completion of MLN8237 administration

          -  Ability to understand and the willingness to sign a written informed consent document

          -  According to current guidelines, patients must be able to take oral medication and to
             maintain a fast as required for 2 hours before and 1 hour after MLN8237
             administration; these guidelines may change pending results from an ongoing food
             effects study

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 4 weeks earlier

          -  Patients who are receiving any other investigational agents

          -  Patients with known brain metastases should be excluded from this clinical trial

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to MLN8237, including but not limited to established allergic reaction to
             benzodiazepines

          -  Treatment with valproic acid within 14 days prior to initiation of study and during
             the study

          -  Prior use of valproic acid or any other histone deacetylase (HDAC) inhibitor for
             lymphoma treatment

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with MLN8237

          -  Human Immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy are ineligible; appropriate studies will be undertaken in patients receiving
             combination antiretroviral therapy when indicated

          -  Known history of uncontrolled sleep apnea syndrome and other conditions that could
             result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary
             disease; requirement for supplemental oxygen; or any conditions that could result in
             excessive toxicity associated with the benzodiazepine-like effects of MLN8237

          -  Requirement for constant administration of proton pump inhibitor, histamine (H2)
             antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are
             allowed

          -  Inability to swallow oral medication or to maintain a fast as required for 2 hours
             before and 1 hour after MLN8237 administration or any condition that would modify
             small bowel absorption of oral medications, including malabsorption, or resection of
             pancreas or upper bowel

          -  Treatment with clinically significant enzyme inducers, such as the enzyme-inducing
             antiepileptic drugs phenytoin, carbamazepine, oxcarbazepine, primidone or
             phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days
             prior to the first dose of MLN8237 and during the study

          -  Patients with New York Heart Association (NYHA) class II-IV heart failure
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tanya Siddiqi, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01567709

Organization ID

NCI-2012-00715

Secondary IDs

NCI-2012-00715

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Tanya Siddiqi, Principal Investigator, City of Hope Comprehensive Cancer Center


Verification Date

April 2018