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A Randomized Double-Blind Placebo-Controlled Phase III Study To Evaluate The Safety And Efficacy Of Palivizumab Combined With Aerosolized Ribavirin Compared To Ribavirin Alone To Treat RSV Pneumonia In Patients With Bone Marrow Transplants (BMT)


Phase 3
N/A
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Randomized Double-Blind Placebo-Controlled Phase III Study To Evaluate The Safety And Efficacy Of Palivizumab Combined With Aerosolized Ribavirin Compared To Ribavirin Alone To Treat RSV Pneumonia In Patients With Bone Marrow Transplants (BMT)


OBJECTIVES: I. Compare the efficacy, in terms of all-cause mortality reduction, of ribavirin
with or without palivizumab in patients with respiratory syncytial virus pneumonia following
stem cell transplantation. II. Determine the safety of these treatments in this patient
population.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to prior ribavirin exposure for this infection (24 hours or more vs
less than 24 hours) and requirement for ventilator support (yes vs no). Patients are
randomized to one of two treatment arms. Arm I: Patients receive aerosolized ribavirin via
face mask or oxygen tent over 2 hours 3 times daily or over 16-18 hours on days 1-10 and
palivizumab IV 2 hours before ribavirin administration on day 1. Arm II: Patients receive
aerosolized ribavirin as in arm I and placebo IV 2 hours before ribavirin administration on
day 1. Patients are followed at 14, 21, and 28 days.

PROJECTED ACCRUAL: A total of 140 patients (70 per arm) will be accrued for this study
within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Confirmed respiratory syncytial virus (RSV) pneumonia documented
by rapid antigen test (ELISA or IFA), shell vial culture of bronchoalveolar lavage
specimens, or tissue antigen staining of lung biopsy sample New infiltrate on chest x-ray
and at least one of the following: Cough Wheezing Dyspnea and/or tachypnea (greater than
150% of baseline) Oxygen saturation less than 90% on two occasions 1 hour apart on room
air Arterial oxygen pressure less than 80 No more than 60 hours since confirmation of
pneumonia by chest x-ray Received prior stem cell transplantation and meet one of the
following: Between start of conditioning (preparative) regimen and day 90 after
allogeneic, autologous, or syngeneic stem cell transplantation (SCT) Between days 91 and
180 after unrelated HLA mismatch-related allogeneic SCT (bone marrow, peripheral blood
stem cells (PBSC), or cord blood), T-cell depleted allogeneic transplantation, or CD34
selected allogeneic PBSC transplantation Between days 91 and 180 after SCT with
graft-versus-host disease requiring systemic steroids expected to continue throughout
study Other pulmonary pathogens in addition to RSV allowed

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy:
At least 48 hours Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: No prior adverse reaction to ribavirin or palivizumab No allergy to monoclonal
antibodies HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 3 months
since prior immunotherapy for respiratory syncytial virus (RSV) including RSV hyperimmune
globulin or other RSV monoclonal antibodies Concurrent IV immunoglobulin allowed No prior
experimental RSV vaccine No concurrent RSV hyperimmune globulin No other concurrent
RSV-specific monoclonal antibodies Chemotherapy: Not specified Endocrine therapy: See
Disease Characteristics Radiotherapy: Not specified Surgery: Not specified Other: At least
4 weeks since prior investigational products for respiratory viral diseases At least 3
months since prior anti-viral drugs with specific anti-RSV activity Prior aerosolized
ribavirin allowed No other concurrent anti-viral drugs with specific anti-RSV activity
Concurrent ganciclovir or foscarnet allowed Ventilator support allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Michael Boeckh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1379.00

NCT ID:

NCT00014391

Start Date:

February 1999

Completion Date:

October 2001

Related Keywords:

  • Cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • refractory multiple myeloma
  • recurrent childhood rhabdomyosarcoma
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • disseminated neuroblastoma
  • recurrent neuroblastoma
  • recurrent Wilms tumor and other childhood kidney tumors
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • recurrent childhood lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • stage III malignant testicular germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • chronic idiopathic myelofibrosis
  • childhood acute promyelocytic leukemia (M3)
  • testicular embryonal carcinoma
  • testicular choriocarcinoma
  • testicular teratoma
  • testicular yolk sac tumor
  • testicular embryonal carcinoma and teratoma
  • testicular embryonal carcinoma and teratoma with seminoma
  • testicular embryonal carcinoma and yolk sac tumor
  • testicular embryonal carcinoma and yolk sac tumor with seminoma
  • testicular embryonal carcinoma and seminoma
  • testicular yolk sac tumor and teratoma
  • testicular yolk sac tumor and teratoma with seminoma
  • testicular choriocarcinoma and yolk sac tumor
  • testicular choriocarcinoma and embryonal carcinoma
  • testicular choriocarcinoma and teratoma
  • testicular choriocarcinoma and seminoma
  • refractory hairy cell leukemia
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent ovarian germ cell tumor
  • ovarian yolk sac tumor
  • ovarian embryonal carcinoma
  • ovarian polyembryoma
  • ovarian choriocarcinoma
  • ovarian immature teratoma
  • ovarian mature teratoma
  • ovarian monodermal and highly specialized teratoma
  • ovarian mixed germ cell tumor
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • poor prognosis metastatic gestational trophoblastic tumor
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • infection
  • pulmonary complications
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • previously treated childhood rhabdomyosarcoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • childhood myelodysplastic syndromes
  • Lymphoma, Non-Hodgkin
  • Pneumonia
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109