Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)
Condition: Sarcoma; Nausea; Vomiting
MeSH terms: Sarcoma; Nausea; Vomiting
Study type: Interventional

Summary: 
      The goal of this clinical research study is to compare 2 treatment schedules of Aloxi
      (palonosetron) in patients with sarcoma who are receiving chemotherapy with adriamycin and
      ifosfamide. The safety of the drug and schedules will be studied. The effect of palonosetron
      on patients' quality of life (QOL) will also be studied.
    

Detailed description: 
      Palonosetron is a drug that is designed to prevent and treat nausea and vomiting that is
      caused by chemotherapy.

      If you are found to be eligible to take part in this study, you will have several blood
      samples taken (about 3 teaspoons each). Researchers will use the samples to monitor blood
      counts during chemotherapy and periods of myelosuppression (a condition in which bone marrow
      activity is decreased). These blood samples will be taken at least 2 times a week, and at
      certain times, they will be taken once a day. You will be asked to fill out a QOL
      questionnaire about nausea and vomiting, at least 2 times during Cycle 1 (one cycle lasts 21
      days). It will take about 10 minutes to complete the questionnaire.

      You will be randomly assigned (as in the toss of a coin) to one of two treatment groups.
      Participants in one group will receive one dose of palonosetron on Day 0. Participants in the
      other group will receive 3 doses of palonosetron on Days 0, 2, and 4. Palonosetron will be
      given to participants in both groups, as an intravenous (IV--through a needle in your vein)
      infusion over 30 minutes.

      You will be asked to keep a study diary during the treatment period. Study personnel will
      give you the diary and tell you how to complete it. Your side effects (including how severe
      they are) and medication doses need to be recorded in your diary every day. You will be asked
      to return your diary at each post-treatment return visit (about every 3 weeks).

      While you are on this study, you will receive chemotherapy as part of your standard
      treatment. All participants will receive at least 2 cycles of adriamycin and ifosfamide
      chemotherapy (AI). A cycle is 3 weeks long. You may receive up to 6 cycles of adriamycin and
      ifosfamide. Adriamycin will be given as one large injection through a central venous catheter
      (plastic tube and needle placed under the collarbone) on Day 0. Ifosfamide will be given over
      3 hours every day for 4 days (Days 0-3). Zinecard will be given as one large injection
      through the catheter on Day 0. Mesna will be given as a 24-hour infusion every day for 4 days
      through the same catheter (Days 0-3). Zinecard and mesna are given as standard of care.
      Zinecard is used to protect against heart-related side effects. Mesna is used to protect
      against bladder-related side effects. For patients with certain types of sarcoma, vincristine
      will be given through the catheter by rapid infusion on Day 0 only.

      You may be treated as an outpatient or an inpatient. You will be asked to return to M.
      D.Anderson every 3 weeks for evaluation of your disease, by having a chest x-ray, a
      computerized tomography (CT) scan, a magnetic resonance imaging (MRI) scan, and a physical
      exam performed. Additional blood samples (about 3 teaspoons) will be taken before each cycle
      and as often as needed to measure your blood counts and electrolytes (minerals in the body)
      to monitor any imbalances.

      You will be asked to contact the study doctor or nurse about any bad side effects you
      experience or any medications (over-the-counter or prescription) you take during the
      treatment period. You will also be asked to notify your other doctors (separate from the
      study doctors) that you are participating in this research study.

      Your treatment will continue for at least 6 cycles, unless your disease gets worse or you
      experience intolerable side effects. If you experience any intolerable side effects or your
      disease gets worse while on this study, you may be taken off this study.

      Once you stop treatment, you will have what is called an end-of-study visit. During this
      visit, you will be evaluated for your disease status with CT and MRI scans. You will have
      your vital signs and weight measured. You will be asked about any medications you have taken
      since your last visit and any bad side effects that you have experienced. You will also have
      a final blood draw (about 3 teaspoons) for routine tests.

      Your participation in this study should end at about 18 weeks (4 to 5 months).

      Once you go off this study, you will have standard follow-up as is required by your doctor.

      This is an investigational study. Palonosetron is FDA approved and is commercially available.

      Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
    

Intervention name(s): Palonosetron - Single Dose; Palonosetron - Triple Dose; Adriamycin; Ifosfamide chemotherapy (AI); Zinecard; Mesna; Vincristine; Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.25 mg by vein for 1 dose (day 0).; 0.25 mg by vein for 3 doses (days 0, 2, 4).; 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.; Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2). Cycle is 3 weeks, up to 6 cycles.; 750 mg/m2 as an IV bolus.; 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hour for days 0, 1, 2, and 3 (infusion completing on day 4).; 2 mg IV by rapid administration on day 0 (for patients with small cell histology).
For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only.; IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.
Other intervention name(s): Aloxi; Aloxi; Doxorubicin; Doxorubicin Hydrochloride; Adriamycin PFS; Adrimaycin RDF; Rubex; Ifex; Dexrazoxane; mesnex; Decadron; Dexamethasone acetate
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Vincristine; Ifosfamide; Dexrazoxane; Palonosetron; BB 1101
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sarcoma; Palonosetron; Aloxi; Nausea; Vomiting