Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)NCT01795430
Whole-Body Radiation Therapy, Systemic Chemotherapy, and High-Dose Chemotherapy Followed By Stem Cell Rescue in Treating Patients With Poor-Risk Ewing Sarcoma
A study testing etoposide, ifosfamide and intensity-modulated radiation therapy in people with Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) and Ewing Sarcoma of Bone, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This pilot clinical trial studies whole-body radiation therapy, systemic chemotherapy, and high-dose chemotherapy followed by stem cell rescue in treating patients with poor-risk Ewing sarcoma. Read more about this study
- Who is it for?
- Ages 6 months to 40 years
- Conditions the study is for
- Adult Supratentorial Primitive Neuroectodermal Tumor (PNET), Ewing Sarcoma of Bone, Extraosseous Ewing Sarcoma
- What is being tested?
- etoposide, ifosfamide and intensity-modulated radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 months to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with relapsed Ewing's sarcoma or primitive neuroectodermal tumor (PNET) with bony/soft tissue metastasis who achieved at least partial response (PR) to chemotherapy, surgery or radiotherapy
- Newly diagnosed patients with metastatic disease to the bones: patients with metastatic Ewing's or metastatic PNET who achieved at least partial response (PR) to chemotherapy, surgery or radiotherapy are eligible
- Ewing's sarcoma/PNET histology confirmed by Anatomic Pathology Department; histological confirmation of relapse is highly recommended but not mandatory
- Patients must have documented at least partial response (PR) to previous therapy regimens; previous modalities may include surgery, chemotherapy, or radiation therapy; radiation must not include lung fields; only patients in CR or PR at the primary site will be eligible
- Patients must have metastatic/recurrent disease identified by WB-MRI at the time of study entry; intensity-modulated radiation therapy (IMRT) can be delivered per protocol guidelines to at least one but not more than five primary/metastatic sites
- Patients must have Karnofsky performance status > 60% OR Lansky performance status > 50% for patients younger than 16 years old
Show all 23Show fewer
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- Adequate number of autologous stem cells collected and cryopreserved prior to starting the study treatment
- Creatinine clearance (12 or 24 hour urine collection) or glomerular filtration rate (GFR) > 60 ml/min/1.73 m^2
- Ejection fraction > 50% by echocardiogram or multiple gated acquisition (MUGA)
- Bilirubin < 2 x upper limit of normal
- Serum glutamic oxalo-acetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 5 x upper limit of normal
- Platelet count > 50,000/ul
- Absolute granulocyte count >= 750/ul
- Forced expiratory volume in one second (FEV1) > 2 liters adults (older than 16 years)
- Room air arterial oxygen pressure (PaO2) > 70 mm Hg adults (older than 16 years)
- Room air partial pressure of carbon dioxide (PaCO2) < 42 mm Hg adults (older than 16 years)
- Diffusion capacity of carbon monoxide (DLCO) > 50% predicted
- If unable to cooperate with pulmonary function testing due to young age, then pulse oximetry >= 94% children (younger than 16 years)
- Pretreatment tests must have been performed within 4 weeks prior to initiation of protocol treatment
- No other medical and/or psychosocial problems which, in the opinion of the primary physician or principal investigator, would place the patient at unacceptable risk from this regimen
- Greater than 2 week period of recovery from prior modality used to control primary or recurrent site
- All subjects or their legal guardians must have the ability to understand and the willingness to sign a written informed consent
Who cannot join
- Patients should not have any uncontrolled illness including ongoing or active infection
- Patients may not be receiving any other investigational agents, concurrent biological agents, or chemotherapy
- Patients must not have received prior chemotherapy or radiation within 2 weeks before study enrollment, and those who have not recovered from the adverse events due to agents administered more than 2 weeks earlier are excluded
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this study
- Patients with other active malignancies are ineligible for this study
- Patients with prior treatment with myeloablative therapy are excluded
Show all 9Show fewer
- Karnofsky performance status < 60% or Lansky performance status < 50% for patients younger than 16 years old
- Patients who require irradiation to more than 5 disease sites are excluded
- Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Pilot Study of Whole-body MRI-guided Intensity Modulated Radiation Therapy Combined With Systemic Chemotherapy Followed by High-Dose Chemotherapy With Busulfan, Melphalan and Topotecan and Stem Cell Rescue in Patients With Poor Risk Ewing's Sarcoma
This pilot clinical trial studies whole-body radiation therapy, systemic chemotherapy, and high-dose chemotherapy followed by stem cell rescue in treating patients with poor-risk Ewing sarcoma. Giving chemotherapy and radiation therapy before a peripheral blood stem cell or bone marrow transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is given to prepare the bone marrow for stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the safety and feasibility of whole-body magnetic resonance imaging (WB-MRI)-guided intensity modulated radiation therapy delivered concurrently with systemic chemotherapy to sites of metastatic disease in patients with relapsed, refractory and/or poor risk Ewing sarcoma.
II. To assess the safety and feasibility of a novel consolidation regimen consisting of busulfan, melphalan and topotecan (topotecan hydrochloride) followed by autologous stem cell rescue, to be administered immediately after completion of radiation therapy in patients with relapsed, refractory and/or poor risk Ewing sarcoma.
SECONDARY OBJECTIVES:
- To characterize the timing of myeloid and platelet engraftment.
II. To estimate the overall and progression free survival probabilities.
III. To estimate the cumulative incidence of relapse/progression and non-relapse related mortality.
IV. To report the overall response rate (overall response rate [ORR]: complete response [CR]+partial response [PR]) and response duration.
- To descriptively compare the diagnostic imaging results (number and site of bone metastases) of whole-body MR imaging to those obtained by skeletal scintigraphy.
OUTLINE:
BLOCK I: Patients receive etoposide intravenously (IV) over 1-2 hours and ifosfamide IV over 1 hour on days 1-5. Patients also undergo WB-MRI-guided intensity-modulated radiation therapy twice daily (BID), 5 days a week, for approximately 4 weeks. Patients may also undergo 4 fractions of stereotactic radiation therapy (SRT) every other day (QOD), 3-8 fractions of stereotactic body radiation therapy (SBRT) QOD, or 10 fractions of 3-dimensional radiation therapy (3D RT) daily to sites of metastatic disease.
BLOCK II: Patients receive high-dose chemotherapy comprising topotecan hydrochloride IV continuously over 24 hours on days -8 to -4, busulfan IV over 2 hours every 6 hours on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Patients undergo autologous peripheral blood or bone marrow stem cell infusion on day 0.
After the stem cell infusion, patients are followed up for up to 5 years.
- Conditions
- Adult Supratentorial Primitive Neuroectodermal Tumor (PNET), Ewing Sarcoma of Bone, Extraosseous Ewing Sarcoma, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Being tested
- etoposide, ifosfamide, intensity-modulated radiation therapy, topotecan hydrochloride, busulfan
- Medical subject headings
- Neuroectodermal Tumors, Primitive, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoposideDrug
Also called EPEG, VP-16, VP-16-213
Given IV
ifosfamideDrug
Also called Cyfos, Holoxan, IFF, IFX
Given IV
intensity-modulated radiation therapyRadiation
Also called IMRT
Undergo WB-MRI-guided IMRT
topotecan hydrochlorideDrug
Also called hycamptamine, Hycamtin, SKF S-104864-A, TOPO
Given IV
busulfanDrug
Also called BSF, BU, Misulfan, Mitosan
Given IV
melphalanDrug
Also called Alkeran, CB-3025, L-PAM, L-phenylalanine mustard
Given IV
autologous hematopoietic stem cell transplantationProcedure or surgery
Undergo autologous peripheral blood stem cell or bone marrow transplant
peripheral blood stem cell transplantationProcedure or surgery
Also called PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Undergo autologous peripheral blood stem cell transplant
autologous bone marrow transplantationProcedure or surgery
Also called ABMT, bone marrow transplantation, autologous, transplantation, autologous bone marrow
Undergo autologous bone marrow transplant
| Study group | Role | What they receive |
|---|---|---|
| Treatment (radiation therapy/chemotherapy, stem cell infusion) | Experimental | BLOCK I: Patients receive etoposide IV over 1-2 hours and ifosfamide IV over 1 hour on days 1-5. Patients also undergo WB-MRI-guided intensity-modulated radiation therapy BID, 5 days a week, for approximately 4 weeks. Patients may also undergo 4 fractions of SRT QOD, 3-8 fractions of SBRT QOD, or 10 fractions of 3D RT daily to sites of metastatic disease.
BLOCK II: Patients receive high-dose chemotherapy comprising topotecan hydrochloride IV continuously over 24 hours on days -8 to -4, busulfan IV over 2 hours every 6 hours on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Patients undergo autologous peripheral blood or bone marrow stem cell infusion on day 0. Receives: Drug: etoposide; Drug: ifosfamide; Radiation: intensity-modulated radiation therapy; Drug: topotecan hydrochloride; Drug: busulfan; Drug: melphalan; Procedure: autologous hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Procedure: autologous bone marrow transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who experience grade 4-5 non-hematologic toxicities assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Toxicities will be summarized as type, severity, date of onset, duration, reversibility, and attribution.
Measured: Up to day 100 of Block II
Secondary outcomes (4)
Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST)
Objective tumor response for all patients will be summarized, including the number and percent responding.
Measured: Up to 5 years
Progression-free survival (PFS)
PFS will be estimated using the Kaplan-Meier product-limit method; 95% confidence intervals (CIs) will be calculated using the logit transformation and the Greenwood variance estimate.
Measured: Time from stem cell infusion to the first observation of disease progression or death from any cause, whichever occurs first, assessed up to 5 years
Overall survival (OS)
OS will be estimated using the Kaplan-Meier product-limit method; 95% confidence intervals (CIs) will be calculated using the logit transformation and the Greenwood variance estimate.
Measured: Time from stem cell infusion to death from any cause, assessed up to 5 years
Non-relapse mortality (NRM)
Cumulative relapse incidence will be estimated treating non-relapse related death events as competing risks and, conversely, NRM will be calculated controlling for relapse as a competing risk. Cumulative incidence of NRM and relapse-related mortality will be calculated using the method of Goole et al. Cumulative incidence differences will be assessed by Gray's test.
Measured: Time from stem cell infusion to death event where the cause of death is not attributable to the underlying disease, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2018 (estimated)
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)Studies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anna Pawlowska, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795430
- Sponsor's protocol ID
- 12391
- Other IDs
- NCI-2013-00439
- Status last verified
- Jan 2015
- First submitted
- 18 Feb 2013
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Whole-body MRI-guided Intensity Modulated Radiation Therapy Combined With Systemic Chemotherapy Followed by High-Dose Chemotherapy With Busulfan, Melphalan and Topotecan and Stem Cell Rescue in Patients With Poor Risk Ewing's Sarcoma
- ClinicalTrials.gov ID
- NCT01795430
- Acronym / sponsor ID
- 12391
- Conditions
- Adult Supratentorial Primitive Neuroectodermal Tumor (PNET), Ewing Sarcoma of Bone, Extraosseous Ewing Sarcoma, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2013
- Primary completion
- Mar 2018 (estimated)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies whole-body radiation therapy, systemic chemotherapy, and high-dose chemotherapy followed by stem cell rescue in treating patients with poor-risk Ewing sarcoma. Giving chemotherapy and radiation therapy before a peripheral blood stem cell or bone marrow transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is given to prepare the bone marrow for stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy
Detailed description
PRIMARY OBJECTIVES:
- To assess the safety and feasibility of whole-body magnetic resonance imaging (WB-MRI)-guided intensity modulated radiation therapy delivered concurrently with systemic chemotherapy to sites of metastatic disease in patients with relapsed, refractory and/or poor risk Ewing sarcoma.
II. To assess the safety and feasibility of a novel consolidation regimen consisting of busulfan, melphalan and topotecan (topotecan hydrochloride) followed by autologous stem cell rescue, to be administered immediately after completion of radiation therapy in patients with relapsed, refractory and/or poor risk Ewing sarcoma.
SECONDARY OBJECTIVES:
- To characterize the timing of myeloid and platelet engraftment.
II. To estimate the overall and progression free survival probabilities.
III. To estimate the cumulative incidence of relapse/progression and non-relapse related mortality.
IV. To report the overall response rate (overall response rate [ORR]: complete response [CR]+partial response [PR]) and response duration.
- To descriptively compare the diagnostic imaging results (number and site of bone metastases) of whole-body MR imaging to those obtained by skeletal scintigraphy.
OUTLINE:
BLOCK I: Patients receive etoposide intravenously (IV) over 1-2 hours and ifosfamide IV over 1 hour on days 1-5. Patients also undergo WB-MRI-guided intensity-modulated radiation therapy twice daily (BID), 5 days a week, for approximately 4 weeks. Patients may also undergo 4 fractions of stereotactic radiation therapy (SRT) every other day (QOD), 3-8 fractions of stereotactic body radiation therapy (SBRT) QOD, or 10 fractions of 3-dimensional radiation therapy (3D RT) daily to sites of metastatic disease.
BLOCK II: Patients receive high-dose chemotherapy comprising topotecan hydrochloride IV continuously over 24 hours on days -8 to -4, busulfan IV over 2 hours every 6 hours on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Patients undergo autologous peripheral blood or bone marrow stem cell infusion on day 0.
After the stem cell infusion, patients are followed up for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (radiation therapy/chemotherapy, stem cell infusion) | Experimental | Drug: etoposide, Drug: ifosfamide, Radiation: intensity-modulated radiation therapy, Drug: topotecan hydrochloride, Drug: busulfan, Drug: melphalan, Procedure: autologous hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantation, Procedure: autologous bone marrow transplantationBLOCK I: Patients receive etoposide IV over 1-2 hours and ifosfamide IV over 1 hour on days 1-5. Patients also undergo WB-MRI-guided intensity-modulated radiation therapy BID, 5 days a week, for approximately 4 weeks. Patients may also undergo 4 fractions of SRT QOD, 3-8 fractions of SBRT QOD, or 10 fractions of 3D RT daily to sites of metastatic disease. BLOCK II: Patients receive high-dose chemotherapy comprising topotecan hydrochloride IV continuously over 24 hours on days -8 to -4, busulfan IV over 2 hours every 6 hours on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Patients undergo autologous peripheral blood or bone marrow stem cell infusion on day 0. |
Who may qualify
- Ages
- 6 months to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (23 listed)
- Patients with relapsed Ewing's sarcoma or primitive neuroectodermal tumor (PNET) with bony/soft tissue metastasis who achieved at least partial response (PR) to chemotherapy, surgery or radiotherapy
- Newly diagnosed patients with metastatic disease to the bones: patients with metastatic Ewing's or metastatic PNET who achieved at least partial response (PR) to chemotherapy, surgery or radiotherapy are eligible
- Ewing's sarcoma/PNET histology confirmed by Anatomic Pathology Department; histological confirmation of relapse is highly recommended but not mandatory
- Patients must have documented at least partial response (PR) to previous therapy regimens; previous modalities may include surgery, chemotherapy, or radiation therapy; radiation must not include lung fields; only patients in CR or PR at the primary site will be eligible
- Patients must have metastatic/recurrent disease identified by WB-MRI at the time of study entry; intensity-modulated radiation therapy (IMRT) can be delivered per protocol guidelines to at least one but not more than five primary/metastatic sites
Key exclusion criteria (9 listed)
- Patients should not have any uncontrolled illness including ongoing or active infection
- Patients may not be receiving any other investigational agents, concurrent biological agents, or chemotherapy
- Patients must not have received prior chemotherapy or radiation within 2 weeks before study enrollment, and those who have not recovered from the adverse events due to agents administered more than 2 weeks earlier are excluded
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this study
- Patients with other active malignancies are ineligible for this study
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 |
|---|---|---|
| etoposideAlso: EPEG, VP-16, VP-16-213Given IV | Drug | Treatment (radiation therapy/chemotherapy, stem cell infusion) |
| ifosfamideAlso: Cyfos, Holoxan, IFF, IFXGiven IV | Drug | Treatment (radiation therapy/chemotherapy, stem cell infusion) |
| intensity-modulated radiation therapyAlso: IMRTUndergo WB-MRI-guided IMRT | Radiation | Treatment (radiation therapy/chemotherapy, stem cell infusion) |
| topotecan hydrochlorideAlso: hycamptamine, Hycamtin, SKF S-104864-A, TOPOGiven IV | Drug | Treatment (radiation therapy/chemotherapy, stem cell infusion) |
| busulfanAlso: BSF, BU, Misulfan, MitosanGiven IV | Drug | Treatment (radiation therapy/chemotherapy, stem cell infusion) |
| melphalanAlso: Alkeran, CB-3025, L-PAM, L-phenylalanine mustardGiven IV | Drug | Treatment (radiation therapy/chemotherapy, stem cell infusion) |
| autologous hematopoietic stem cell transplantationUndergo autologous peripheral blood stem cell or bone marrow transplant | Procedure or surgery | Treatment (radiation therapy/chemotherapy, stem cell infusion) |
| peripheral blood stem cell transplantationAlso: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cellUndergo autologous peripheral blood stem cell transplant | Procedure or surgery | Treatment (radiation therapy/chemotherapy, stem cell infusion) |
| autologous bone marrow transplantationAlso: ABMT, bone marrow transplantation, autologous, transplantation, autologous bone marrowUndergo autologous bone marrow transplant | Procedure or surgery | Treatment (radiation therapy/chemotherapy, stem cell infusion) |
Primary outcome
Percentage of patients who experience grade 4-5 non-hematologic toxicities assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to day 100 of Block II
Toxicities will be summarized as type, severity, date of onset, duration, reversibility, and attribution.
4 secondary outcomes
Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 5 years
Progression-free survival (PFS)
Time frame: Time from stem cell infusion to the first observation of disease progression or death from any cause, whichever occurs first, assessed up to 5 years
Overall survival (OS)
Time frame: Time from stem cell infusion to death from any cause, assessed up to 5 years
Non-relapse mortality (NRM)
Time frame: Time from stem cell infusion to death event where the cause of death is not attributable to the underlying disease, assessed up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
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.
Anna Pawlowska principal investigator
City of Hope Medical 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 etoposide, ifosfamide and intensity-modulated radiation therapy in people with Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) and Ewing Sarcoma of Bone, run by City of Hope Medical 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 23 inclusion and 9 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: withdrawn, as of the sponsor's last update on 9 Jan 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of patients who experience grade 4-5 non-hematologic toxicities assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (time frame: Up to day 100 of Block II). 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 9 Jan 2015.