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OsteosarcomaPhase 2NCT07321912

Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

A Phase 2 study testing Eflornithine, Topotecan and Cyclophosphamide in people with Osteosarcoma and Ewing Sarcoma, run by Milton S. Hershey Medical Center at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Ewing sarcoma (EWS) and osteosarcoma primarily affect adolescents and young adults. Common treatments include chemotherapy, surgery and radiation, however, there have been few recent advancements in the standard of care. Read more about this study

Who is it for?
Ages 0 to 50 years
Conditions the study is for
Osteosarcoma, Ewing Sarcoma
What is being tested?
Eflornithine, Topotecan and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
3 sitesUnited States
Study dates
5 Jun 2026to 1 Jun 2036
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 0 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Participants must be ≤50 years of age at enrollment.
  • Histologically confirmed Ewing sarcoma that is refractory or in first or subsequent relapse. Histological confirmation either at initial diagnosis or disease progression.
  • Relapsed: Participants that have achieved CR at any point and then relapsed following/during standard of care therapy.
  • Refractory: Participants that failed to achieve CR after standard of care therapy or having progressed during standard of care therapy.
  • Note: Standard of care therapy for Ewing sarcoma includes multi-agent chemotherapy with local control consisting of either surgery and/or radiation therapy.
  • Extent of disease is judged by treating team to be amenable to the delivery of definitive local control (either definitive radiation, surgery, or a combination of these) at the time of study enrollment (to be completed after protocol defined Cycle 2).
Show all 126Show fewer
  • Participants may enroll anytime during Cycle 1 or 2, prior to local control, as long as they received the same treatment during Cycle 1 and 2 as prescribed in this protocol.
  • Relapsed or refractory disease, including at least one of the following:
  • Tumor by CT or MRI
  • FDG-PET that is positive for disease
  • Bone Marrow biopsy/aspirate that is positive for disease
  • Organ Function Requirements:
  • Participants must have adequate renal function as defined as:
  • For participants < 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Bedside Schwartz equation is: [(0.413) X (Height in cm)] / SCr
  • For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Cockcroft and Gault formula is: [(140-age) x (Wt in kg) x (0.85 if female)] / (72 x SCr)
  • OR a 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2
  • Adequate liver function defined as:
  • Total bilirubin ≤1.5 x upper limit of normal (ULN) for age, and
  • SGPT (ALT <3 x upper limit of normal (ULN) for age (except for participants with liver metastasis who may enroll if ALT < 5 times ULN for age).
  • Adequate cardiac function defined as:
  • Shortening fraction of ≥27% or
  • Ejection fraction of ≥50%
  • Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.
  • Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.
  • Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.
  • Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).
  • Age
  • Participants must be ≤50 years of age at enrollment.
  • Note:
  • Infants and small children are eligible for this study, however, the treating physicians and family must be prepared to deliver adequate local control as required in this study (see BCC Surgical and Imaging Guidelines).
  • Diagnosis
  • Participants with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site.
  • For the purpose of this study, metastatic disease is defined as one or more of the following:
  • Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor. Skip lesions in the same bone as the primary tumor do not constitute metastatic disease. Skip lesions in an adjacent bone are considered bone metastases. If there is any doubt whether lesions are metastatic, a biopsy of those lesions should be performed.
  • Contralateral pleural effusion and/or contralateral pleural nodules.
  • Distant lymph node involvement.
  • Participants with pulmonary nodules are considered to have metastatic disease if the participant has:
  • Solitary nodule ≥0.5 cm or multiple nodules of ≥0.3 cm unless lesion is biopsied and negative for tumor;
  • Participants with solitary nodule <0.5 cm or multiple nodules <0.3 cm are not considered to have lung metastasis unless biopsy documents tumor.
  • Bone marrow metastatic disease is based on morphologic evidence of Ewing sarcoma based on H\&E stains. In the absence of morphologic evidence of marrow involvement on H\&E, participants with bone marrow involvement detected ONLY by flow cytometry, RT PCR, FISH, or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study.
  • For participants that have a positive FDG-PET scan at study enrollment, a bilateral bone marrow biopsy will be required at study entry. If a bone marrow is required, the suggested approach for participants with large pelvic tumors in which a posterior iliac crest bone marrow biopsy would track through the tumor is to instead undergo 2 marrow biopsies on the contralateral side (either 2 posterior biopsies or one posterior and one anterior biopsy).
  • Bone metastasis: This study utilizes whole body FDG-PET scans to screen participants for bone metastases. Areas suspicious for bone metastasis based on FDG-PET scans require confirmatory anatomic imaging with either MRI or CT (whole body FDG-PET/CT or FDG-PET/MR scan acceptable). Whole body technetium bone scans may be performed at the discretion of the investigator and are not required. For participants without other sites of metastatic disease whose sole metastatic site to qualify for study entry is a single area suspicious for bone metastasis identified by FDG-PET, confirmatory biopsy or anatomic imaging evidence of an associated soft tissue mass at that site is required for study entry.
  • Prior Therapy
  • Participants must have completed 6 cycles of Induction therapy with VDC/IE per US standard of care (including standard modifications). Participants will enroll after the 6th cycle prior to local control.
  • Organ Function Requirements
  • Adequate renal function defined as:
  • For participants < 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Bedside Schwartz equation is: [(0.413) X (Height in cm)] / SCr
  • For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Cockcroft and Gault formula is: [(140-age) x (Wt in kg) x (0.85 if female)] / (72 x SCr)
  • OR a 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2
  • Adequate liver function defined as:
  • Total bilirubin ≤1.5 x upper limit of normal (ULN) for age, and
  • SGPT (ALT <3 x upper limit of normal (ULN) for age (except for participants with liver metastasis who may enroll if ALT < 5 times ULN for age).
  • Adequate cardiac function defined as:
  • Shortening fraction of ≥27% or
  • Ejection fraction of ≥50%
  • Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.
  • Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.
  • Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.
  • Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).
  • Age
  • Participants must be less than 30 years of age at enrollment.
  • Diagnosis
  • Participants must have histologic diagnosis of osteosarcoma at original diagnosis.
  • Participants must have had at least one episode of disease recurrence in the lungs without limitation on number of episodes of recurrence as long as they meet the following criteria:
  • Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 4 weeks prior to study enrollment*
  • Pathologic confirmation of metastases from at least one of the resected sites.
  • No local recurrence or metastatic disease elsewhere. *For participants with bilateral pulmonary metastases, resection must be performed from both lungs and the study enrollment must be within 4 weeks from date of the last lung surgery. No evidence of pulmonary metastatic disease; participants may have no visible lung nodules greater than 3 mm, and not considered to be disease.
  • Note: If surgery related changes such as atelectasis are seen on the post-operative CT scan, participants will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected. Participants with positive microscopic margins will be eligible to enroll.
  • Performance Level
  • Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.
  • Timing from Prior Therapy
  • Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  • Myelosuppressive anti-cancer therapy: Must not have been received within 2 weeks of study entry (4 weeks if prior nitrosourea).
  • Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.
  • Radiation therapy (RT): ≥2 weeks for local palliative RT (small port); ≥6 weeks must have elapsed if prior craniospinal RT or if ≥50% radiation of pelvis; ≥6 weeks must have elapsed if other substantial BM radiation.
  • Surgery: ≥2 weeks from last major surgery, including pulmonary metastasectomy, with the exclusion of a central line placement and core needle or small open biopsies.
  • Organ Function Requirements
  • Hematological:
  • Platelet count ≥50,000/μL without transfusion in last 7 days
  • Hgb ≥8.5 without transfusion in last 7 days
  • Adequate renal function defined as:
  • For participants < 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Bedside Schwartz equation is: [(0.413) X (Height in cm)] / SCr
  • For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Cockcroft and Gault formula is: [(140-age) x (Wt in kg) x (0.85 if female)] / (72 x SCr)
  • OR a 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2
  • Adequate liver function defined as:
  • Total bilirubin ≤1.5 x upper limit of normal (ULN) for age.
  • SGPT (ALT <3 x upper limit of normal (ULN) for age.
  • Adequate cardiac function defined as:
  • Shortening fraction of ≥27%, or
  • Ejection fraction of ≥50%.
  • Adequate pulmonary function defined as:
  • o No evidence of dyspnea at rest, no history of exercise intolerance, and a pulse oximetry >94%.
  • Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.
  • Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).
  • Diagnosis Both Cohorts
  • Participants must have high grade osteosarcoma and received gross total resection prior to start of Cycle 3 MAP therapy. Participants with positive margins are eligible and may receive radiation therapy. This includes secondary malignancies.
  • o Note: craniofacial osteosarcoma is NOT permitted.
  • The primary tumor was resectable after the initial 2 cycles of MAP chemotherapy.
  • Participants must have had a non-contrast chest CT and primary tumor site imaging consisting of an MRI or CT for optimal visualization of primary tumor site prior to local control. Physical scans and scan reports must be available to submit to BCC.
  • Note: Two-view plain radiographs of the primary tumor site can be performed for participants who have a metallic prosthetic implant instead of CT or MRI if a significant metal artifact would occur by those imaging modalities;
  • Cohort A only
  • Participant must have poor response to induction chemotherapy (those with 10% or more viable tumor remaining after surgery) and localized tumor.
  • Cohort B only
  • Have an initial diagnosis of high-grade metastatic extremity or axial osteosarcoma resectable by the treating team.
  • o Note: Metastatic pulmonary disease is defined as 3 or more lesions >5 mm or 1 lesion >1 cm or biopsy proven pulmonary metastatic disease if not meeting these radiographic criteria;
  • No definite progression of metastatic disease and no evidence of new metastatic disease.
  • Following definitive primary surgery, complete removal of all metastases or complete removal planned and deemed feasible.
  • Non-Diagnostic Inclusion Criteria, Both Cohorts Age
  • Participants must be ≥5 years and ≤40 years on date of diagnostic biopsy. Performance Level
  • Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60. Participants whose performance status is adversely affected by a pathologic fracture but who are able to undergo treatment are eligible.
  • Prior Therapy
  • Participants must have completed standard induction therapy for initial diagnosis osteosarcoma (2 cycles [10weeks]) of MAP, Local control (surgery, assessment of histologic response), and a post-surgery 3rd cycle (5 weeks) of MAP. Participants will enroll after the 3rd cycle of MAP.
  • Organ Function Requirements
  • Participants must have adequate renal function defined:
  • For participants < 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Bedside Schwartz equation is: [(0.413) X (Height in cm)] / SCr
  • For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Cockcroft and Gault formula is: [(140-age) x (Wt in kg) x (0.85 if female)] / (72 x SCr)
  • OR a 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2
  • Adequate cardiac function defined as:
  • Shortening fraction of ≥28%, or
  • Ejection fraction of ≥50%
  • Adequate liver function defined as:
  • Total bilirubin ≤1.5 x upper limit of normal (ULN) for age
  • SGPT (ALT <3 x upper limit of normal (ULN) for age.
  • Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.
  • Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.
  • Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).

Who cannot join

  • BSA of <0.25 m2
  • Participants with current CNS disease.
  • Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.
  • Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.
  • Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
  • Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
Show all 32Show fewer
  • Cohort 2:
  • BSA of <0.25 m2
  • Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.
  • Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.
  • Participants with regional node involvement as their only site of disease beyond the primary tumor.
  • Participants whose primary tumors arise in the intra-dural soft tissue (e.g. brain and spinal cord).
  • Participants with current CNS disease
  • Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
  • Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
  • Cohort 3:
  • BSA of <0.25 m2
  • Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.
  • Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.
  • Participants with distant bone metastases at original diagnosis or any subsequent relapse (participants with only skip lesions will be eligible).
  • Participants with concurrent local and pulmonary recurrence at the time of most recent episode of disease recurrence preceding enrollment.
  • Note: participants who had local recurrence previously that has been treated and then presented with an isolated pulmonary recurrence and met the surgical resection criteria stated above will be eligible (see IC #3 above).
  • Participants with primary refractory disease with progression of the primary tumor on initial therapy.
  • Participants with other sites of extra-pulmonary metastases at the time of any episode of disease recurrence preceding enrollment.
  • Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
  • Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in who compliance is likely to be suboptimal.
  • Cohort 4A/B:
  • BSA of <0.25 m2
  • Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.
  • Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.
  • Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
  • Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in who compliance is likely to be suboptimal.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

BCC Enroll contact

7175310003

BCCEnroll@pennstatehealth.psu.edu

United States3 sites, 3 recruiting

  • Penn State Milton S. Hershey Medical Center and Children's Hospital

    Hershey, Pennsylvania, 17033

    Penn State Clinical Trials Group Email, ExtractClinicalTrials@pennstatehealth.psu.edu

    Valerie Brown, MD

    Recruiting

  • Randall Children's Hospital

    Portland, Oregon, 97227

    Aaron White, AJWHITE@lhs.org

    Jason Glover

    Recruiting

  • St. Joseph's Children's Hospital

    Tampa, Florida, 33614

    Jennifer Manns, jennifer.manns@baycare.org

    Don Eslin

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Open Label Basket Trial Study Using Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

Ewing sarcoma (EWS) and osteosarcoma primarily affect adolescents and young adults. Common treatments include chemotherapy, surgery and radiation, however, there have been few recent advancements in the standard of care. By incorporating eflornithine (DFMO) as an additional therapy and/or maintenance therapy we hope to safely observe improved event-free survival and overall survival. There are 5 cohorts covered under this master protocol.

Being tested
Eflornithine, Topotecan, Cyclophosphamide, Vincristine, Doxorubicin
Medical subject headings
Osteosarcoma, Sarcoma, Ewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07321912
Study groupRoleWhat they receive
Cohort 1: Relapsed or Refractory Ewing Sarcoma Eligible to Receive Local ControlExperimentalDFMO will be administered as concurrent therapy during treatment of Ewing sarcoma. Participants completing treatment without experiencing an analytic event will continue to receive DFMO monotherapy as a maintenance treatment for an additional 24 months.
Receives: Drug: Eflornithine; Drug: Topotecan; Drug: Cyclophosphamide
Cohort 2: Ewing Sarcoma Patients who are Metastatic at DiagnosisExperimentalDFMO will be administered as concurrent therapy during consolidation treatment of metastatic Ewing sarcoma. Participants completing consolidation treatment without experiencing an analytic event will continue to receive DFMO monotherapy as a post consolidation maintenance treatment for an additional 24 months.
Receives: Drug: Eflornithine; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin; Drug: Ifosfamide; Drug: Etoposide
Cohort 3: Osteosarcoma with relapse in the lung after resection of lung metastasesExperimentalDFMO will be dosed twice daily for 730 days.
Receives: Drug: Eflornithine
Cohort 4A: Osteosarcoma with Poor Response to Induction Therapy at Completion of Local ControlExperimentalDFMO will be administered as concurrent therapy during Cycles 4-6 of post-surgery consolidation. Participants completing MAP without experiencing an analytic event will continue to receive DFMO monotherapy as a post consolidation maintenance treatment for an additional 24 months.
Receives: Drug: Eflornithine; Drug: Doxorubicin; Drug: Cisplatin; Drug: Methotrexate
Cohort 4B: Osteosarcoma with Metastatic Disease at Diagnosis at Completion of Local ControlExperimentalDFMO will be administered as concurrent therapy during Cycles 4-6 of post-surgery consolidation. Participants completing MAP without experiencing an analytic event will continue to receive DFMO monotherapy as a post consolidation maintenance treatment for an additional 24 months.
Receives: Drug: Eflornithine; Drug: Doxorubicin; Drug: Cisplatin; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Cohort 1 participants with relapse free survival (RFS) during study

    Cohort 1: To determine if relapse-free survival (RFS) in participants with relapsed or refractory Ewing sarcoma treated with multiagent chemotherapy is improved with the addition of DFMO as compared to historical outcomes of participants treated with the same multiagent chemotherapy without DFMO.

    Measured: 2 years plus 5 years follow up

  2. Number of Cohort 2 participants with event-free survival (EFS) during study

    Cohort 2: To determine if event-free survival (EFS) in participants with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy is improved with the addition of DFMO as compared to historical outcomes of participants treated with the same multiagent chemotherapy without DFMO.

    Measured: 2 years plus 5 years follow up

  3. Cohort 3: Number of Cohort 3 participants at 12 months with disease control

    To determine the 12-month disease control rate (DCR) in participants with completely resected recurrent osteosarcoma treated with DFMO as compared to historical controls.

    Measured: 1 year plus 5 years follow up

  4. Cohort 4A: Number of Cohort 4A participants with event-free survival (EFS) during study

    Examine whether the addition of DFMO to post-operative chemotherapy with cisplatin, doxorubicin, and methotrexate (MAP) improves the event-free survival (EFS) for participants with osteosarcoma having localized disease with a poor histological response to 10 weeks of pre-operative chemotherapy.

    Measured: 2 years plus 5 years follow up

  5. Cohort 4B: Number of Cohort 4B participants with event-free survival (EFS) during study

    Examine whether the addition of DFMO to post-operative chemotherapy with cisplatin, doxorubicin, and methotrexate (MAP) improves the event-free survival (EFS) for participants with osteosarcoma with metastatic disease at diagnosis (Cohort 4B).

    Measured: 2 years plus 5 years follow up

Secondary outcomes (2)

  1. Length of time that participants experience Overall Survival (OS)

    To compare overall survival in DFMO-treated participants versus historical controls.

    Measured: 10 Years

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    To characterize safety and tolerability of DFMO plus multiagent chemotherapy.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start5 Jun 2026
  3. Primary completion1 Jun 2031 (estimated)
  4. Study completion1 Jun 2036 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
406 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07321912
Sponsor's protocol ID
BCC023
Status last verified
Oct 2026
First submitted
5 Jan 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eflornithine, Topotecan and Cyclophosphamide in people with Osteosarcoma and Ewing Sarcoma, run by Milton S. Hershey Medical Center at 3 sites 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 126 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BCC Enroll (7175310003, BCCEnroll@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Cohort 1 participants with relapse free survival (RFS) during study (time frame: 2 years plus 5 years follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07321912.

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 6 Oct 2026.

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