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Rituximab and Galiximab in Treating Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

1 juli 2016 bijgewerkt door: Alliance for Clinical Trials in Oncology

A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #12373) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)

RATIONALE: Monoclonal antibodies, such as rituximab and galiximab, 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. Giving more than one monoclonal antibody may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying how well giving rituximab together with galiximab works in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

OBJECTIVES:

Primary

  • Determine the overall and complete response rate in patients with previously untreated CD20-positive bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma treated with rituximab and galiximab.
  • Determine the time to disease progression in patients treated with this regimen.

Secondary

  • Determine the toxicity profile of this regimen in these patients.
  • Correlate Fc receptor polymorphism profiling with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction therapy (month 1): Patients receive rituximab IV on days 1, 8, 15, and 22 and galiximab IV over 1 hour on day 3, 8, 15, and 22.
  • Extended induction therapy (months 3, 5, 7, and 9): Beginning in month 3, patients receive rituximab and galiximab as above on day 1. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 4 months for up to 10 years.

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study within 18 months.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

62

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Florida
      • Fort Lauderdale, Florida, Verenigde Staten, 33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Hollywood, Florida, Verenigde Staten, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jupiter, Florida, Verenigde Staten, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami Beach, Florida, Verenigde Staten, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Canton, Illinois, Verenigde Staten, 61520
        • Graham Hospital
      • Carthage, Illinois, Verenigde Staten, 62321
        • Memorial Hospital
      • Chicago, Illinois, Verenigde Staten, 60637-1470
        • University of Chicago Cancer Research Center
      • Eureka, Illinois, Verenigde Staten, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, Verenigde Staten, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, Verenigde Staten, 61401
        • Galesburg Clinic
      • Havana, Illinois, Verenigde Staten, 62644
        • Mason District Hospital
      • Hopedale, Illinois, Verenigde Staten, 61747
        • Hopedale Medical Complex
      • Kewanee, Illinois, Verenigde Staten, 61443
        • Kewanee Hospital
      • Macomb, Illinois, Verenigde Staten, 61455
        • Mcdonough District Hospital
      • Normal, Illinois, Verenigde Staten, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Verenigde Staten, 61761
        • Community Cancer Center
      • Ottawa, Illinois, Verenigde Staten, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Verenigde Staten, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, Verenigde Staten, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, Verenigde Staten, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Verenigde Staten, 61614
        • Proctor Hospital
      • Peoria, Illinois, Verenigde Staten, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Verenigde Staten, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, Verenigde Staten, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, Verenigde Staten, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, Verenigde Staten, 61362
        • St. Margaret's Hospital
    • Indiana
      • Fort Wayne, Indiana, Verenigde Staten, 46815
        • Fort Wayne Medical Oncology and Hematology
    • Iowa
      • Cedar Rapids, Iowa, Verenigde Staten, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, Verenigde Staten, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Cedar Rapids, Iowa, Verenigde Staten, 52402
        • Iowa Blood and Cancer Care
      • Iowa City, Iowa, Verenigde Staten, 52242
        • Holden Comprehensive Cancer Center at University of Iowa
    • Maine
      • Bangor, Maine, Verenigde Staten, 04401
        • CancerCare of Maine at Eastern Maine Medial Center
    • Massachusetts
      • Worcester, Massachusetts, Verenigde Staten, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55417
        • Veterans Affairs Medical Center - Minneapolis
    • Missouri
      • Columbia, Missouri, Verenigde Staten, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Jefferson City, Missouri, Verenigde Staten, 65101
        • Capital Region Cancer Center
      • St Louis, Missouri, Verenigde Staten, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
      • St. Louis, Missouri, Verenigde Staten, 63131
        • Missouri Baptist Cancer Center
    • New Hampshire
      • Hooksett, New Hampshire, Verenigde Staten, 03106
        • New Hampshire Oncology-Hematology, PA - Hooksett
      • Keene, New Hampshire, Verenigde Staten, 03431
        • Kingsbury Center for Cancer Care at Cheshire Medical Center
      • Lebanon, New Hampshire, Verenigde Staten, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
      • Manchester, New Hampshire, Verenigde Staten, 03103
        • Elliot Regional Cancer Center
      • Rochester, New Hampshire, Verenigde Staten, 03867
        • Frisbie Memorial Hospital
    • New York
      • Buffalo, New York, Verenigde Staten, 14263-0001
        • Roswell Park Cancer Institute
      • Glens Falls, New York, Verenigde Staten, 12801
        • Charles R. Wood Cancer Center at Glens Falls Hospital
      • New Hyde Park, New York, Verenigde Staten, 11042
        • Long Island Jewish Medical Center
      • New York, New York, Verenigde Staten, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Verenigde Staten, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • Syracuse, New York, Verenigde Staten, 13215
        • Community General Hospital of Greater Syracuse
      • Syracuse, New York, Verenigde Staten, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
    • North Carolina
      • Gastonia, North Carolina, Verenigde Staten, 28053
        • CaroMont Cancer Center at Gaston Memorial Hospital
      • Goldsboro, North Carolina, Verenigde Staten, 27534
        • Wayne Radiation Oncology
      • Goldsboro, North Carolina, Verenigde Staten, 27534
        • Wayne Memorial Hospital, Incorporated
      • Hendersonville, North Carolina, Verenigde Staten, 28791
        • Pardee Memorial Hospital
      • Kinston, North Carolina, Verenigde Staten, 28501
        • Lenoir Memorial Cancer Center
      • Wilson, North Carolina, Verenigde Staten, 27893-3428
        • Wilson Medical Center
      • Winston-Salem, North Carolina, Verenigde Staten, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, Verenigde Staten, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15224-1791
        • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    • South Carolina
      • Florence, South Carolina, Verenigde Staten, 29501
        • McLeod Regional Medical Center
      • Greenville, South Carolina, Verenigde Staten, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, Verenigde Staten, 29601
        • Bon Secours St. Francis Health System
    • Vermont
      • Berlin, Vermont, Verenigde Staten, 05602
        • Mountainview Medical
      • Burlington, Vermont, Verenigde Staten, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Danville, Virginia, Verenigde Staten, 24541
        • Danville Regional Medical Center
      • Martinsville, Virginia, Verenigde Staten, 24115
        • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
    • West Virginia
      • Huntington, West Virginia, Verenigde Staten, 25702
        • St. Mary's Regional Cancer Center at St. Mary's Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

  1. Documentation of Disease

    1.1 Previously untreated, histologically confirmed follicular lymphoma, WHO classification, grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) which is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II.

    1.1.1 Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies. Fine needle aspirates are not acceptable.

    1.1.2 Failure to submit pathology specimens within 60 days of patient registration will result in the patient being declared ineligible.

    1.2 Institutional flow cytometry or immunohistochemistry must confirm CD20 antigen expression.

    1.3 Patients classified as high risk according to the Follicular Lymphoma International Prognostic Index (FLIPI) should be considered for CALGB 50102/SWOG S0016 (A Phase III Trial of CHOP vs CHOP + Rituximab vs CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody [Tositumomab] For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas).

  2. Prior Treatment

    2.1 No prior therapy for non-Hodgkin lymphoma including chemotherapy, radiation or immunotherapy (e.g., monoclonal antibody-based therapy)

    2.2 No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease

  3. Age - Patients must be ≥ 18 years of age
  4. ECOG Performance Status - Patients must have ECOG Performance Status 0-2.

  5. Measurable Disease - Measurable disease must be present either on physical examination or imaging studies.

    5.1 Non-measurable disease alone is not acceptable.

    5.2 Any tumor mass > 1 cm is acceptable.

    5.3 Lesions that are considered non-measurable include the following:

    • Bone lesions (lesions if present should be noted)
    • Ascites
    • Pleural/pericardial effusion
    • Lymphangitis cutis/pulmonis
    • Bone marrow (involvement by non-Hodgkin lymphoma should be noted).
  6. CNS Involvement - Patients must have no known CNS involvement by lymphoma.

  7. HIV Infection - Patients must have no known HIV infection.

    7.1 Patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus.

    7.2 Patients who test positive or who are known to be infected are not eligible due to an increased risk of infection with this regimen. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk.

  8. Human Anti-Chimeric Antibody - Patients must have no known baseline human anti-chimeric antibody (HACA) positivity.

  9. Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing.

    9.1 Due to the unknown teratogenic potential of galiximab, pregnant or nursing patients may not be enrolled.

    9.2 Women and men of reproductive potential should agree to use an effective means of birth control throughout their participation in this study.

    9.3 Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom).

  10. Second Malignancy - Patients with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible.

    10.1 This includes Waldenstrom's Macroglobulinemia, since such patients have experienced transient increases in IgM following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis.

    10.2 Patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse.

  11. Required Initial Laboratory Values:

    • ANC ≥ 1000/µL
    • Platelet Count ≥ 50,000/µL
    • Creatinine ≤ 2 x ULN Unless attributable to lymphoma
    • Total Bilirubin ≤ 2 x ULN*† Unless attributable to Gilbert's disease

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall response
Tijdsspanne: 12 months
complete and partial response will be assessed
12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alliance for Clinical Trials in Oncology

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Myron S. Czuczman, MD, Roswell Park Cancer Institute

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2005

Primaire voltooiing (Werkelijk)

1 juni 2007

Studie voltooiing (Werkelijk)

1 augustus 2013

Studieregistratiedata

Eerst ingediend

8 juli 2005

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2005

Eerst geplaatst (Schatting)

11 juli 2005

Updates van studierecords

Laatste update geplaatst (Schatting)

6 juli 2016

Laatste update ingediend die voldeed aan QC-criteria

1 juli 2016

Laatst geverifieerd

1 juli 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CALGB-50402
  • U10CA031946 (Subsidie/contract van de Amerikaanse NIH)
  • CDR0000433340 (Register-ID: NCI Physician Data Query)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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