SarcomaNCT00410488
Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)
A study testing Palonosetron - Single Dose, Palonosetron - Triple Dose and Adriamycin in people with Sarcoma and Nausea, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Palonosetron - Single Dose, Palonosetron - Triple Dose and Adriamycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with AI is indicated.
- Must be between the ages of 18 and 65 years of age.
- Patients with childbearing potential (defined as not post menopausal for 12 months or no previous surgical sterilization) must use adequate birth control.
- Adequate hematologic (Absolute neutrophil count (ANC)>/= 1500/mm^3, >/= hemoglobin (Hgb, Hb) 10gm/dL, platelet count >/= 150,000/mm^3), renal (serum creatinine </= 1.5 mg/dL), hepatic (serum bilirubin count </= 1.5 * normal and Serum glutamic pyruvic transaminase (SGPT) <3 * normal) functions.
- Karnofsky Performance Status >/= 80.
- Signed informed consent form.
Who cannot join
- Pregnant or lactating women.
- Patients with comorbid condition which renders patients at high risk of treatment complication.
- Patients with symptomatic or untreated metastatic disease to CNS.
- Patients with significant cardiac disease (New York Heart Association (NYHA) Class III or IV), arrhythmia, or recent history of Myocardial infarction (MI) or ischemia.
- Patients with known hypersensitivity to 5-HT3 antagonists.
- Any vomiting or >/= grade 2 nausea in the 24 hours preceding chemotherapy.
- Ongoing vomiting from any organic etiology.
- Radiotherapy within 2 weeks of study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI)
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.
Read the 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.
- Being tested
- Palonosetron - Single Dose, Palonosetron - Triple Dose, Adriamycin, Ifosfamide chemotherapy (AI), Zinecard
- Keywords
- Sarcoma, Palonosetron, Aloxi, Nausea, Vomiting
- Medical subject headings
- Sarcoma, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palonosetron - Single DoseDrug
Also called Aloxi
0.25 mg by vein for 1 dose (day 0).
Palonosetron - Triple DoseDrug
Also called Aloxi
0.25 mg by vein for 3 doses (days 0, 2, 4).
AdriamycinDrug
Also called Doxorubicin, Doxorubicin Hydrochloride, Adriamycin PFS, Adrimaycin RDF
75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.
Ifosfamide chemotherapy (AI)Drug
Also called Ifex
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.
ZinecardDrug
Also called Dexrazoxane
750 mg/m2 as an IV bolus.
MesnaDrug
Also called mesnex
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).
VincristineDrug
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.
DexamethasoneDrug
Also called Decadron, Dexamethasone acetate
IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron - 1 Dose | Active comparator | 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). Receives: Drug: Palonosetron - Single Dose; Drug: Adriamycin; Drug: Ifosfamide chemotherapy (AI); Drug: Zinecard; Drug: Mesna; Drug: Vincristine; Drug: Dexamethasone |
| Palonosetron - 3 Doses | Active comparator | 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). Receives: Drug: Palonosetron - Triple Dose; Drug: Adriamycin; Drug: Ifosfamide chemotherapy (AI); Drug: Zinecard; Drug: Mesna; Drug: Vincristine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palonosetron Response Rate in the 10 Day Study Cycle
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Saroj Vadhan-Raj, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410488
- Sponsor's protocol ID
- 2005-0664
- Status last verified
- Feb 2013
- First submitted
- 11 Dec 2006
- Last updated
- 22 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI)
- ClinicalTrials.gov ID
- NCT00410488
- Acronym / sponsor ID
- 2005-0664
- Keywords
- Sarcoma, Palonosetron, Aloxi, Nausea, Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Dec 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Dec 2006 (estimated)
- Results
- Posted 22 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palonosetron - 1 Dose | Active comparator | Drug: Palonosetron - Single Dose, Drug: Adriamycin, Drug: Ifosfamide chemotherapy (AI), Drug: Zinecard, Drug: Mesna, Drug: Vincristine, Drug: DexamethasoneArm 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). |
| Palonosetron - 3 Doses | Active comparator | Drug: Palonosetron - Triple Dose, Drug: Adriamycin, Drug: Ifosfamide chemotherapy (AI), Drug: Zinecard, Drug: Mesna, Drug: Vincristine, Drug: DexamethasoneArm 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with AI is indicated.
- Must be between the ages of 18 and 65 years of age.
- Patients with childbearing potential (defined as not post menopausal for 12 months or no previous surgical sterilization) must use adequate birth control.
- Adequate hematologic (Absolute neutrophil count (ANC)>/= 1500/mm^3, >/= hemoglobin (Hgb, Hb) 10gm/dL, platelet count >/= 150,000/mm^3), renal (serum creatinine </= 1.5 mg/dL), hepatic (serum bilirubin count </= 1.5 * normal and Serum glutamic pyruvic transaminase (SGPT) <3 * normal) functions.
- Karnofsky Performance Status >/= 80.
Key exclusion criteria (8 listed)
- Pregnant or lactating women.
- Patients with comorbid condition which renders patients at high risk of treatment complication.
- Patients with symptomatic or untreated metastatic disease to CNS.
- Patients with significant cardiac disease (New York Heart Association (NYHA) Class III or IV), arrhythmia, or recent history of Myocardial infarction (MI) or ischemia.
- Patients with known hypersensitivity to 5-HT3 antagonists.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palonosetron - Single DoseAlso: Aloxi0.25 mg by vein for 1 dose (day 0). | Drug | Palonosetron - 1 Dose |
| Palonosetron - Triple DoseAlso: Aloxi0.25 mg by vein for 3 doses (days 0, 2, 4). | Drug | Palonosetron - 3 Doses |
| AdriamycinAlso: Doxorubicin, Doxorubicin Hydrochloride, Adriamycin PFS, Adrimaycin RDF75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. | Drug | Palonosetron - 1 Dose, Palonosetron - 3 Doses |
| Ifosfamide chemotherapy (AI)Also: IfexIfosfamide: 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. | Drug | Palonosetron - 1 Dose, Palonosetron - 3 Doses |
| ZinecardAlso: Dexrazoxane750 mg/m2 as an IV bolus. | Drug | Palonosetron - 1 Dose, Palonosetron - 3 Doses |
| MesnaAlso: mesnex500 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). | Drug | Palonosetron - 1 Dose, Palonosetron - 3 Doses |
| Vincristine2 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. | Drug | Palonosetron - 1 Dose, Palonosetron - 3 Doses |
| DexamethasoneAlso: Decadron, Dexamethasone acetateIV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. | Drug | Palonosetron - 1 Dose, Palonosetron - 3 Doses |
Primary outcome
Palonosetron Response Rate in the 10 Day Study Cycle
Time frame: 10 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saroj Vadhan-Raj, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palonosetron - Single Dose, Palonosetron - Triple Dose and Adriamycin in people with Sarcoma and Nausea, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palonosetron Response Rate in the 10 Day Study Cycle (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.