Monoclonal Antibody Therapy and Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin’s Lymphoma

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Macroglobulinemia and in IgM-MGUS Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia Perifosine in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia Randomised Trial in Waldenstrom’s Macroglobulinaemia A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom’s Macroglobulinemia (WM) Pomalidomide, Dexamethasone and Rituximab in Waldenstrom’s Macroglobulinemia Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia Study of Epratuzumab (hLL2) in Patients With Waldenstrom’s Macroglobulinemia A Study for Patients That Have Been Previously Been Treated in Waldenstrom’s Macroglobulinemia or Multiple Myeloma Ibrutinib With Rituximab in Adults With Waldenström’s Macroglobulinemia Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom’s 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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

Monoclonal Antibody Therapy and Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma

Official Title

Dose Finding Study of IDEC-Y2B8 With Autologous Stem Cell Support

Brief Summary

      This phase I trial is studying how well monoclonal antibody therapy with peripheral stem cell
      transplant works in treating patients with non-Hodgkin's lymphoma. Monoclonal antibodies,
      such as rituximab, can block cancer 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
      cancer-killing substances to them. Peripheral stem cell transplant may allow the doctor to
      give higher doses of monoclonal antibodies and kill more cancer cells
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the maximum tolerated dose of IDEC-Y2B8 when administered with rituximab in
      vivo purging and autologous stem cell rescue.

      II. To obtain correlative laboratory data of in vivo purging with rituximab in patients with
      0-35% marrow involvement.

      OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan
      (IDEC-Y2B8).

      PART I: Patients receive rituximab IV on days 1, 8, 15, and 22 and cyclophosphamide IV over 1
      hour on day 25. Filgrastim (G-CSF) is administered subcutaneously (SC) daily beginning on day
      26 and continuing until autologous peripheral blood stem cells (PBSC) are harvested.

      PART II: Beginning 4-6 weeks after completion of the fourth rituximab infusion, patients
      receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 followed by dosimetry
      imaging on days 1, 2, 4, and 7. Patients then receive IDEC-Y2B8 IV over 10 minutes once
      between days 8-15.

      The initial 3 patients receive the same dose of IDEC-Y2B8 and then subsequent cohorts of 3-5
      patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose is
      determined.

      PART III: All patients undergo PBSC transplantation (PBSCT) beginning after residual bone
      marrow radioactivity resolves. G-CSF is administered SC beginning 1 day after PBSCT and
      continuing until blood counts recover.

      Patients are followed every 3 months for 1 year and then every 6 months thereafter.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

MTD, defined in terms of clinical toxicities graded using the CTC version 2.0


Condition

Contiguous Stage II Adult Diffuse Large Cell Lymphoma

Intervention

rituximab

Study Arms / Comparison Groups

 Treatment
Description:  PART I: Patients receive rituximab IV on days 1, 8, 15, and 22 and cyclophosphamide IV over 1 hour on day 25. G-CSF is administered SC daily beginning on day 26 and continuing until autologous PBSC are harvested.
PART II: Beginning 4-6 weeks after completion of the fourth rituximab infusion, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 followed by dosimetry imaging on days 1, 2, 4, and 7. Patients then receive IDEC-Y2B8 IV over 10 minutes once between days 8-15.
PART III: All patients undergo PBSCT beginning after residual bone marrow radioactivity resolves. G-CSF is administered SC beginning 1 day after PBSCT and continuing until blood counts recover.

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

Biological

Estimated Enrollment

30

Start Date

April 2001


Primary Completion Date

December 2007

Eligibility Criteria

        Inclusion Criteria:

          -  All patients must have a biopsy-proven indolent or diffuse large B-cell non-Hodgkin's
             lymphoma as defined as REAL classification marginal zone/MALT, mantle cell,
             plasmacytoid, lymphoplasmacytoid, small lymphocytic lymphoma or follicle center grades
             I, II, III or diffuse large B-cell (CLL patients will not be eligible); transformation
             from a low grade to intermediate or high grade lymphoma is also permissible; patients
             with diffuse large cell lymphoma must not be eligible for any known potentially
             curative therapy; at least one diagnostic pathologic specimen will be reviewed by the
             JHH Pathology Department

          -  Patients must have received at least one but not more than five prior chemotherapy
             regimens for treatment of their lymphoma

          -  Patients may not have received prior external beam radiation therapy to > 25% of
             active bone marrow (involved field or regional)

          -  Patients must have 0-35% morphologically identifiable tumor in the trabecular space on
             bone marrow biopsy; in patients with lymphomas in whom tumor is morphologically
             difficult to distinguish from normal cells, flow cytometry must show 0-35%
             identifiable tumor within 4 weeks of registration

          -  Patients must have =< 35% bone marrow involvement with tumor due to risk of
             engraftment failure

          -  Patients may not have hypocellular bone marrow (=< 15% cellularity) or marked decrease
             in any one (or more) hematopoietic precursor

          -  Patients may not have received prior murine compounds due to risk of HAMA formation

          -  WBC must be >= 3,000

          -  Total lymphocyte count must be < 5,000

          -  Hgb must be >= 10.0

          -  Platelets must be >= 75,000

          -  Serum creatinine must not be greater than 2.0 mg/dl

          -  Direct bilirubin must be =< 2mg/dl unless secondary to tumor

          -  AST or ALT must be < 2 x the upper limit of normal

          -  Normal (>= 45%) left ventricular cardiac ejection fraction, (determined by
             echocardiogram or MUGA scan)

          -  DLCO must be > 50% predicted

          -  Patients with active infections requiring oral or intravenous antibiotics are not
             eligible for entry onto the study until resolution of the infection

          -  ECOG performance status =< 2

          -  Not pregnant (confirmed by serum pregnancy test in females of reproductive potential)
             or breast feeding, because it is unknown what effect these drugs will have on children

          -  Women of childbearing potential and sexually active males are strongly advised to use
             an accepted and effective method of contraception

          -  Patients with a second malignancy other than basal cell carcinoma or squamous cell
             carcinoma of the skin or in situ carcinoma of the cervix are not eligible unless the
             tumor was treated with curative intent at least two years previously

          -  Women and minorities are encouraged to participate

          -  Patients who have received prior anti-CD20 therapy must have achieved a partial or
             complete response

          -  Patients who are HIV positive will be excluded due to increased risk for bone marrow
             suppression and other toxicities

          -  Patients who have received prior radioimmunotherapy, for example Zevalin or Bexxar,
             are not eligible
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Lode Swinnen, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00017381

Organization ID

NCI-2012-03156

Secondary IDs

J0004

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Lode Swinnen, Principal Investigator, Johns Hopkins University


Verification Date

January 2013