17-N-Allylamino-17-Demethoxygeldanamycin and Bortezomib in Treating Patients With Relapsed or Refractory Hematologic Cancer

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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

17-N-Allylamino-17-Demethoxygeldanamycin and Bortezomib in Treating Patients With Relapsed or Refractory Hematologic Cancer

Official Title

A Phase I Study of PS-341 (Velcade, Bortezomib) in Combination With 17-allylamino-17-demethoxygeldanamycin (17-AAG) in Patients With Relapsed or Refractory Hematologic Malignancies

Brief Summary

      This phase I trial is studying the side effects and best dose of
      17-N-allylamino-17-demethoxygeldanamycin and bortezomib in treating patients with relapsed or
      refractory hematologic cancer. Drugs used in chemotherapy, such as
      17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the
      growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving
      17-N-allylamino-17-demethoxygeldanamycin together with bortezomib may kill more cancer cells.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the maximum tolerated dose (MTD) of PS-341 (Velcade, Bortezomib) in
      combination with 17-allyamino-17-demethoxygeldanamycin (17-AAG) in patients with relapsed or
      refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL).

      II. To determine the MTD of PS-341 in combination with 17-AAG in patients with relapsed or
      refractory chronic lymphocytic leukemia (CLL), and non-Hodgkin's lymphoma (NHL).

      III. To define the specific toxicities and the dose limiting toxicity (DLT) of PS-341 in
      combination with 17-AAG in the treatment of patients with relapsed or refractory hematologic
      malignancies.

      SECONDARY OBJECTIVES:

      I. To determine the pharmacokinetics of 17-AAG alone and in combination with PS-341 in
      patients with AML, ALL, CLL, and NHL.

      II. To evaluate 20S proteasome inhibition following combination therapy with 17-AAG and
      PS-341 in patients with AML, ALL, CLL, and NHL.

      III. To assess the relationship between FLT3 mutational status and leukemic cell response to
      PS-341 and 17-AAG in patients with AML.

      IV. To assess the relationship between Bcl-2 over-expression and response to 17-AAG and
      PS-341 in patients with AML and NHL.

      V. To evaluate the effects of the combination of PS-341 and 17-AAG on Hsp90 and NF-kappaB and
      their downstream targets including Hsp70, Akt, phosphorylated Akt, p21, and caspases 3 and 9
      in patient-derived primary AML and NHL cells.

      OUTLINE: This is a dose-escalation study. Patients are stratified according to diagnosis
      (acute myeloid leukemia [AML] or acute lymphoblastic leukemia vs chronic lymphoctyic leukemia
      or non-Hodgkin's lymphoma [NHL]).

      Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) intravenously (IV) over
      1-6 hours on days 1, 4, 8, and 11 and bortezomib IV over 3-5 seconds on days 4, 8, and 11 of
      course 1 and on days 1, 4, 8, and 11 of all subsequent courses.

      Treatment repeats every 21 days for 3-12 courses provided patient is receiving clinical
      benefit. Patients achieving objective response may discontinue therapy to undergo stem cell
      transplantation.Cohorts of 3-6 patients with receive escalating doses of 17-AAG and
      bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
      dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

      After the MTD is determined, an additional 20 patients (10 per stratum with AML or follicular
      NHL) are enrolled and receive 17-AAG and bortezomib as above at the MTD.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum tolerated dose (MTD) of bortezomib) in combination with 17-AAG)


Condition

Adult Acute Basophilic Leukemia

Intervention

tanespimycin

Study Arms / Comparison Groups

 Treatment (17-AAG and bortezomib)
Description:  Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-6 hours on days 1, 4, 8, and 11 and bortezomib IV over 3-5 seconds on days 4, 8, and 11 of course 1 and on days 1, 4, 8, and 11 of all subsequent courses.
Treatment repeats every 21 days for 3-12 courses provided patient is receiving clinical benefit. Patients achieving objective response may discontinue therapy to undergo stem cell transplantation.

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

74

Start Date

April 2005


Primary Completion Date

April 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of 1 of the following hematologic
             malignancies:

               -  Acute myeloid leukemia or acute lymphoblastic leukemia

                    -  Not a candidate for potentially curative therapy

                    -  WBC ≤ 10,000/mm^3 OR WBC ≤ 40,000/mm^3 that is stable for 5 days
                       (hydroxyurea allowed)

                    -  No acute promyelocytic leukemia

               -  Non-Hodgkin's lymphoma (NHL), including 1 of the following subtypes:

                    -  Small lymphocytic lymphoma

                    -  Marginal zone lymphoma

                    -  Lymphoplasmacytic lymphoma

                    -  Follicular lymphoma

                    -  Mantle cell lymphoma

                    -  Diffuse large B-cell lymphoma

                    -  Anaplastic large cell lymphoma

                    -  Peripheral T-cell lymphoma

                    -  Extranodal NK/T cell lymphoma (nasal and nasal type)

                    -  Enteropathy-type T-cell lymphoma

                    -  Hepatosplenic T-cell lymphoma

                    -  Angioimmunoblastic T-cell lymphoma

                    -  Subcutaneous panniculitis-like T-cell lymphoma

               -  Chronic lymphocytic leukemia (CLL)

          -  Patients with NHL or CLL must meet the following criteria:

               -  Ineligible for, or refused potentially curative stem cell transplantation

               -  Transformed lymphoma/Richter's transformation, defined as the transformation of
                  low-grade lymphoma, including follicular lymphoma, CLL, or small lymphocytic
                  lymphoma to high-grade lymphoma (i.e., diffuse large cell lymphoma) allowed at
                  time of transformation

               -  Evidence of ≥ 50% bone marrow involvement at the time of enrollment OR tumor
                  tissue accessible for biopsy (for patients enrolled after the maximum tolerated
                  dose [MTD] is determined)

               -  Absolute neutrophil count ≥ 1,000/mm^3

               -  Platelet count ≥ 100,000/mm^3

          -  Relapsed or refractory disease

          -  Willing to undergo serial bone marrow biopsy (for patients enrolled after the MTD is
             determined)

          -  No untreated or active CNS leukemia or lymphoma

          -  Performance status - ECOG 0-2

          -  At least 12 weeks

          -  Bilirubin ≤ 1.5 mg/dL

          -  AST and ALT ≤ 2.5 times upper limit of normal

          -  Creatinine ≤ 2.0 mg/dL

          -  No uncontrolled cardiac disease

          -  No New York Heart Association class III-IV symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular
             fibrillation > 3 beats in a row) within the past 6 months

          -  No other uncontrolled cardiac arrhythmia or requiring antiarrhythmic drugs

          -  No myocardial infarction within the past year

          -  No active ischemic heart disease within the past year

          -  No congenital long QT syndrome

          -  No left bundle branch block

          -  QTc ≥ 450 msec (for men) or 470 (for women) on ECG/EKG

          -  No history of LVEF < 50% by MUGA or echocardiogram

          -  Resting ejection fraction ≥ 50% by MUGA or echocardiogram

          -  No prior history of cardiac toxicity after receiving anthracycline therapy (e.g.,
             doxorubicin hydrochloride, daunorubicin hydrochloride, or mitoxantrone hydrochloride)

          -  No uncontrolled pulmonary disease

          -  No symptomatic pulmonary disease requiring oxygen or medications

          -  DLCO (i.e., oxygen diffusion capacity) ≥ 80% on pulmonary function testing

          -  Resting and exercise oxygen saturation ≥ 90% by pulse oximetry

          -  No ongoing pulmonary symptoms ≥ grade 2 including any of the following:

               -  Dyspnea on or off exertion

               -  Paroxysmal nocturnal dyspnea

               -  Significant pulmonary disease including chronic obstructive or restrictive
                  pulmonary disease

               -  No prior history of pulmonary toxicity after bleomycin or carmustine

          -  No Medicare requirement for home oxygen (e.g., Resting O_2 saturation ≥ 90% or
             desaturation to ≥ 90% with exertion)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No preexisting sensory or motor peripheral neuropathy ≥ grade 2

          -  No history of allergic reaction to eggs

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other uncontrolled illness

          -  Prior stem cell transplantation for relapsed or refractory disease allowed

          -  At least 2 weeks since prior immunotherapy and recovered

          -  At least 2 weeks since prior chemotherapy (excluding hydroxyurea) and recovered

          -  No other concurrent chemotherapy

          -  No concurrent routine corticosteroids except for treatment of other medical problems
             (e.g., pulmonary, rheumatologic, or adrenal disorders)

          -  At least 2 weeks since prior radiotherapy and recovered

          -  No prior radiotherapy that potentially included the heart in the field (e.g., mantle)

          -  No prior history of chest radiation

          -  No concurrent palliative radiotherapy

          -  At least 2 weeks since prior investigational therapy

          -  Prior bortezomib allowed

          -  No other concurrent commercial or investigational agents or therapies for the
             malignancy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kristie Blum, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00103272

Organization ID

NCI-2012-01463

Secondary IDs

OSU 0448

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Kristie Blum, Principal Investigator, Ohio State University


Verification Date

June 2013