Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
Condition: Breast Cancer; Chronic Myeloproliferative Disorders; Gestational Trophoblastic Tumor; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Nausea and Vomiting; Neuroblastoma; Ovarian Cancer; Testicular Germ Cell Tumor
MeSH terms: Lymphoma; Neoplasms; Breast Neoplasms; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Neuroblastoma; Neoplasms, Germ Cell and Embryonal; Plasmacytoma; Trophoblastic Neoplasms; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome; Nausea; Vomiting
Study type: Interventional

Summary: 
      RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help
      lessen or prevent nausea and vomiting in patients treated with chemotherapy.

      PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron
      and dexamethasone works in preventing nausea and vomiting in patients receiving
      cyclophosphamide before undergoing an autologous stem cell transplant.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with
           the standard prophylactic anti-emetic combination of granisetron hydrochloride and
           dexamethasone in patients receiving therapy comprising high-dose cyclophosphamide to
           mobilize stem cells prior to leukapheresis for autologous stem cell transplantation.

      Secondary

        -  Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in
           these patients.

        -  Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in
           these patients.

        -  Identify side effects of the addition of aprepitant to this regimen in these patients.

      OUTLINE: Patients receive granisetron hydrochloride orally or IV and oral dexamethasone,
      followed 1 hour later by cyclophosphamide IV over 2 hours on day 1. Patients also receive
      oral aprepitant once daily on days 1-3. Treatment continues in absence of unacceptable
      toxicity.

      After completion of study treatment, patients are followed for 30 days.

      PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
    

Intervention name(s): Aprepitant; Cyclophosphamide; Dexamethasone; Granisetron hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Aprepitant 80mg once daily in the morning on days 2 and 3; Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes; Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.; Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Other intervention name(s): Emend; Cytoxan®; Neosar®; Decadron; Diodex; Hexadrol; Maxidex; Dexamethasone Sodium Phosphate; Dexamethasone Acetate; KYTRIL®
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Cyclophosphamide; Aprepitant; Granisetron; Dexamethasone 21-phosphate; BB 1101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: nausea and vomiting; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); accelerated phase chronic myelogenous leukemia; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia in remission; atypical chronic myeloid leukemia, BCR-ABL negative; blastic phase chronic myelogenous leukemia; chronic eosinophilic leukemia; primary myelofibrosis; chronic myelomonocytic leukemia; chronic neutrophilic leukemia; chronic phase chronic myelogenous leukemia; de novo myelodysplastic syndromes; disseminated neuroblastoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; myelodysplastic/myeloproliferative neoplasm, unclassifiable; nodal marginal zone B-cell lymphoma; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult lymphoblastic 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 mantle cell lymphoma; noncontiguous stage II marginal zone lymphoma; noncontiguous stage II small lymphocytic lymphoma; poor prognosis metastatic gestational trophoblastic tumor; previously treated myelodysplastic syndromes; recurrent adult acute lymphoblastic leukemia; recurrent adult acute myeloid leukemia; recurrent adult Burkitt lymphoma; recurrent adult Hodgkin lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent mycosis fungoides/Sezary syndrome; recurrent neuroblastoma; recurrent ovarian epithelial cancer; recurrent ovarian germ cell tumor; recurrent small lymphocytic lymphoma; recurrent malignant testicular germ cell tumor; refractory chronic lymphocytic leukemia; refractory hairy cell leukemia; refractory multiple myeloma; relapsing chronic myelogenous leukemia; secondary acute myeloid leukemia; secondary myelodysplastic syndromes; splenic marginal zone lymphoma; stage I multiple myeloma; stage II multiple myeloma; stage II ovarian epithelial cancer; stage III adult Burkitt lymphoma; stage III adult Hodgkin lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III chronic lymphocytic leukemia; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III mantle cell lymphoma; stage III marginal zone lymphoma; stage III multiple myeloma; stage III ovarian epithelial cancer; stage III small lymphocytic lymphoma; stage III malignant testicular germ cell tumor; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV adult Burkitt lymphoma; stage IV adult Hodgkin lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV breast cancer; stage IV chronic lymphocytic leukemia; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV mantle cell lymphoma; stage IV marginal zone lymphoma; stage IV ovarian epithelial cancer; stage IV small lymphocytic lymphoma