Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Nausea

Vomiting

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Signs and Symptoms, Digestive

Soft Tissue Sarcoma

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Cardiotonic Agents

Anti-Infective Agents

Dexamethasone

Doxorubicin

Liposomal doxorubicin

Palonosetron

Vincristine

Ifosfamide

Dexamethasone acetate

BB 1101

Isophosphamide mustard

Dexrazoxane

Razoxane

Mesna

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Protective Agents

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).

Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).

Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).

Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).

Palonosetron - Single Dose

0.25 mg by vein for 3 doses (days 0, 2, 4).

Palonosetron - Triple Dose

75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.

Adriamycin

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.

Ifosfamide chemotherapy (AI)

Zinecard

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.

Saroj Vadhan-Raj, MD

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.

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.

Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)

Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI)

Number of participants with dose of palonosetron who experienced response (no emesis) during acute and delayed time period of the study (10 days) divided by number of participants. Complete response defined as no emesis and no rescue medicines in 10 days from the start of chemotherapy in the first chemotherapy cycle.

Eisai Inc.

M.D. Anderson Cancer Center

Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0) and Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).

Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).

Palonosetron - 1 Dose

Palonosetron - 3 Doses

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Saroj Vadhan-Raj, MD / Professor

Palonosetron Response Rate in the 10 Day Study Cycle

Overall Study

Skin and Connective Tissue Diseases

Sarcoma, Ewing

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Ewing Sarcoma

Antirheumatic Agents

Cyclophosphamide

Immunosuppressive Agents

Immunologic Factors

Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days. Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m\^2 IV over 1 hour every week x 50-52 weeks.

Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days, Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin).

2.0 mg/m\^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6.

90 mg/m\^2 IV over 30 min x 1 repeated every 3 weeks X 6.

2.0 g/m\^2 IV daily x 2 days repeated every 3 weeks X 6.

900 mg/m\^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.

900 mcg/m\^2 IV over 1 hour every week x 50-52 weeks.

ImmTher

Eugenie S. Kleinerman, MD

Objectives:

1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free survival seen with standard VAC therapy.
2. To evaluate the feasibility and describe the toxicity associated with VACdxr.
3. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks.
4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.

Patients will be assigned at random (as by the toss of a coin) to receive 1 of 2 treatments.

Arm A: VACdxr will be given over 2 days through a needle in a vein. On day 1, vincristine will be given over 15 minutes, and doxorubicin will be given over 30 minutes.

Dexrazoxane will be given 30 minutes before doxorubicin; this drug protects the heart from damage by doxorubicin. Cyclophosphamide will be given once a day on days 1 and 2. This will make up 1 cycle of VACdxr treatment; the cycle will be repeated every 3 weeks for up to 6 cycles.

To prevent some side effects of VACdxr, the drugs Mesna and Neupogen/or Neulasta will also be given. Mesna helps prevent bladder damage. Neupogen is a growth factor that stimulates the body to make more white blood cells. Neulasta is a growth factor related to Neupogen.

After cycle 3, surgery may be done to remove any tumor that remains. The principal investigator will also decide whether radiation treatment should be done. If so, patients will receive radiation therapy.

Starting 1 month after all treatment is done, patients will receive ImmTher. ImmTher stimulates the body's white blood cells to attack and kill tumor cells. The drug will be given through a needle in a vein over 1 hour, every week for 1 year.

Arm B: Patients will be treated the same as patients in Arm A, except that they will not receive ImmTher.

Patients may have to stay in the hospital during VACdxr treatment and after surgery. Patients will receive ImmTher in the outpatient clinic.

Before treatment starts, patients will have a complete exam including blood and urine tests and an EKG and ECHO or multiple gated acquisition scan (MUGA) (heart function tests). X-rays and CT, MRI, bone marrow aspiration, and bone scans will be done. Women will have a pregnancy test.

After each treatment with drugs, after surgery, and after radiation treatment, patients will have checkups. These will include blood and urine tests and sometimes x-rays.

After cycle 3 of VACdxr, patients will have chest x-ray and x-ray of primary tumor. CT chest, MRI, bone marrow aspiration and bone scans will be done after 3 cycles as indicated. These tests will be done to record and measure tumors.

After treatment stops, patients will return for checkups every 3 months for 2 years.

This is an investigational study. ImmTher is an investigational agent. All other study drugs are approved by the U.S. Food and Drug Administration. As many as 104 patients will take part in the study; about 95 of these will be treated at M.D. Anderson.

Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients

Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma

DFS defined as survival of participants to two years post study entry without relapse.

One participant from Arm A not treated was excluded from AE reporting. Since the study regimen utilizes high dose chemotherapy, grade 4 myelosuppression (neutropenia, leukopenia, granulocytopenia, anemia and thrombocytopenia) \& nausea/vomiting are expected. Constitutional symptoms (fever, chills, fatigue, headache, myalgia) are expected side effects of ImmTher, a biologic agent. A grade 4 toxicity of any of those listed expected events or hospitalizations not be reported as Serious AEs.

Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m\^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m\^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m\^2 IV daily for 2 days. Dexrazoxane 900 mg/m\^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m\^2 IV over 1 hour every week for 50-52 weeks.

Arm A: VACdxr With ImmTher

Arm B: VACdxr

Age, Continuous

Study terminated early leading to small numbers of subjects analyzed; therefore, unable to accrue required number of participants to determine statistical significance.

Dr. Eugenie S. Kleinerman, Professor, Pediatrics - Research

Data was not collected due to early termination of the protocol

2-year Disease-free Survival (DFS): Effect of Treatment With Combination Drugs in VACdxr Given in High Doses With or Without ImmTher to Help Participants With Ewing's Sarcoma Live Longer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)	NCT00410488	Sarcoma Nausea Vomiting	Palonosetron - ... Palonosetron - ... Adriamycin Ifosfamide chem... Zinecard Mesna Vincristine Dexamethasone	18 Years - 65 Years	M.D. Anderson Cancer Center
Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients	NCT00038142	Ewing's Sarcoma	Vincristine Doxorubicin Cyclophosphamid... Dexrazoxane ImmTher	3 Years - 60 Years	M.D. Anderson Cancer Center
Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients	NCT00038142	Ewing's Sarcoma	Vincristine Doxorubicin Cyclophosphamid... Dexrazoxane ImmTher	3 Years - 60 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for zinecard

Every month we try and update this database with for zinecard cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for zinecard

Every month we try and update this database with for zinecard cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for zinecard cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.