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Ewing Sarcoma of BoneNCT00618813

Two Regimens of Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Localized Ewing Sarcoma Family of Tumors

A study testing radiation therapy, therapeutic conventional surgery and etoposide in people with Ewing Sarcoma of Bone and Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, run by Children's Oncology Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial is studying the side effects of combination chemotherapy and to see how well they work in treating patients with newly diagnosed localized Ewing sarcoma family of tumors. Read more about this study

Who is it for?
Ages Up to 30 years
What is being tested?
radiation therapy, therapeutic conventional surgery and etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Mar 2008to Mar 2010
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 Up to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis of extracranial Ewing sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue:
  • Newly diagnosed disease
  • Disease confirmed by biopsy only with no attempt at complete or partial resection
  • Unplanned excision allowed provided adequate imaging was obtained prior to surgery and incompletely resected disease is controlled by local therapy
  • No esthesioneuroblastoma
  • Localized disease, including any of the following sites:
Show all 40Show fewer
  • Chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology, or ipsilateral pleural based secondary tumor nodules;
  • No contralateral pleural effusions or pleural nodules
  • Regional lymph nodes that are clinically suspicious or confirmed by biopsy
  • No distant lymph node metastases
  • Extra-dural tumors arising in the bony skull
  • No tumors arising in the intra-dural soft tissue or the intra-dural region of the spine
  • No evidence of metastatic disease, defined as any of the following:
  • Lesions that are discontinuous from the primary tumor
  • Lesions that are not regional lymph nodes
  • Lesions that do not share a body cavity with the primary tumor
  • No evidence by CT scan of metastatic lung disease, defined as any of the following:
  • One pulmonary nodule > 1 cm in diameter or more than one nodule > 0.5 cm diameter
  • Pulmonary nodules that are resected and are not found to be metastatic Ewing sarcoma are allowed
  • Biopsy proven solitary nodules measuring 0.5 to 1.0 cm or multiple nodules measuring 0.3 to 0.5 cm
  • Solitary nodules measuring < 0.5 cm or multiple nodules measuring < 0.3 cm are allowed unless biopsy proven to be metastatic (biopsy is not required)
  • Karnofsky performance status (PS) 0-2 (>= 16 years old) OR Lansky PS 0-2 (< 16 years old)
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
  • 1 month to < 6 months old (males and females 0.4 mg/dL)
  • 6 months to < 1 year old (males and females 0.5 mg/dL)
  • 1 to < 2 years old (males and females 0.6 mg/dL)
  • 2 to < 6 years old (males and females 0.8 mg/dL)
  • 6 to < 10 years old (males and females 1.0 mg/dL)
  • 10 to < 13 years old (males and females 1.2 mg/dL)
  • 13 to < 16 years old (males 1.5 mg/dL and females 1.4 mg/dL)
  • >= 16 years old (males 1.7 mg/dL and females 1.4 mg/dL)
  • AST or ALT < 2.5 times ULN for age
  • Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
  • Shortening fraction of >= 27% by ECHO or ejection fraction of >= 50% by radionuclide angiogram (MUGA)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior chemotherapy or radiotherapy
  • No concurrent pegfilgrastim (Neulasta) or sargramostim (GM-CSF)
  • No other concurrent cancer chemotherapy or immunomodulating agents, including steroids, unless used as an antiemetic

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Oncology Group

    Monrovia, California, 91016

Other trials in United States

About this study

Official title: A Pilot Study of Chemotherapy Intensification by Adding Vincristine, Topotecan and Cyclophosphamide to Standard Chemotherapy Agents With an Interval Compression Schedule in Newly Diagnosed Patients With Localized Ewing Sarcoma Family of Tumors

This clinical trial is studying the side effects of combination chemotherapy and to see how well they work in treating patients with newly diagnosed localized Ewing sarcoma family of tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the feasibility and safety of adding interval-compressed vincristine, topotecan hydrochloride, and cyclophosphamide to a treatment protocol utilizing interval compression of vincristine, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide in patients with localized Ewing sarcoma family of tumors.

SECONDARY OBJECTIVES:

  1. To estimate the event-free survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

INDUCTION THERAPY (WEEKS 1-12): Patients receive vincristine IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11, and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 1 hour on days 1-5 in weeks 1 and 9 and on day 1 in weeks 5 and 11; ifosfamide IV over 1 hour on days 1-5 in weeks 3 and 7; etoposide IV over 1 hour on days 1-5 in weeks 3 and 7; and doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 5 and 11. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning 24-36 hours after the last dose of chemotherapy and continuing for at least 7 days or until blood counts recover, whichever comes last. Filgrastim is discontinued at least 24 hours prior to the next course of chemotherapy.

LOCAL CONTROL: Patients who respond to induction therapy may undergo surgery alone if the lesion can be resected with negative margins and with a reasonable functional result beginning in week 13. Following surgery, patients with unresectable lesions or inadequate margins may receive radiotherapy during week 15. Patients with bulky lesions in surgically difficult sites such as the spine, skull, and periacetabular pelvis; poor response to induction chemotherapy; or those in whom surgery would result in unacceptable functional results may receive radiotherapy alone in weeks 13-19. Patients with bulky lesions in difficult sites and who do not have a good clinical and radiographic response to induction therapy may receive radiotherapy to the primary site during weeks 13-19 followed by surgery of the involved site during week 25 after recovery from course 11 of chemotherapy. Patients with microscopic residual disease after planned pre-operative radiotherapy will receive additional radiotherapy.

CONTINUATION THERAPY (WEEKS 15-36): Patients receive vincristine IV on day 1 in weeks 15, 16, 21-24, 27-30, 33, and 34; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 15, 21, and 29; cyclophosphamide IV over 1 hour on days 1-5 in weeks 15, 21 and 29 and on day 1 in weeks 23, 27, and 33; ifosfamide IV over 1 hour on days 1-5 in weeks 17, 19, 25, 31, and 35; etoposide IV over 1 hour on days 1-5 in weeks 17, 19, 25, 31, and 35; and doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 of weeks 23, 27, and 33. Patients also receive G-CSF SC as in induction therapy.

After completion of study treatment, patients are followed for 10 years.

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.

  • radiation therapyOther

    Also called irradiation, radiotherapy, therapy, radiation

    Undergo radiation therapy

  • therapeutic conventional surgeryOther

    Undergo surgery

  • etoposideDrug

    Also called EPEG, VP-16, VP-16-213

    Given IV

  • ifosfamideDrug

    Also called Cyfos, Holoxan, IFF, IFX

    Given IV

  • doxorubicin hydrochlorideDrug

    Also called ADM, ADR, Adria, Adriamycin PFS

    Given IV

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • vincristine sulfateDrug

    Also called leurocristine sulfate, VCR, Vincasar PFS

    Given IV

  • topotecan hydrochlorideDrug

    Also called hycamptamine, Hycamtin, SKF S-104864-A, TOPO

    Given IV

  • filgrastimBiological

    Also called G-CSF, Neupogen

    Given SC

Study groups in NCT00618813
Study groupRoleWhat they receive
Treatment (combination chemotherapy)ExperimentalSee Detailed Description
Receives: Other: radiation therapy; Other: therapeutic conventional surgery; Drug: etoposide; Drug: ifosfamide; Drug: doxorubicin hydrochloride; Drug: cyclophosphamide; Drug: vincristine sulfate; Drug: topotecan hydrochloride; Biological: filgrastim

What is being measured

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

  1. Incidence of Death

    Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy

    Measured: Length of protocol therapy (up to 37 weeks) plus 30 days

  2. Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12

    The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.

    Measured: Enrollment to week 12

  3. Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22

    The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.

    Measured: Week 13 to week 22

  4. Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28

    The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.

    Measured: Week 23 to week 28

  5. Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37

    The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.

    Measured: Week 29 to week 37

Secondary outcomes (1)

  1. Event Free Survival

    Disease progression, occurrence of a second malignant neoplasm (SMN)or death will be considered an analytic event. In all other cases, the patient will be considered censored at last contact.

    Measured: From enrollment to event or 10 years from enrollment, whichever occurs first

Timeline

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

  1. First posted20 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMar 2010

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00618813
Sponsor's protocol ID
AEWS07P1
Other IDs
NCI-2009-00371, CDR0000586282, U10CA098543, COG-AEWS07P1
Status last verified
Sep 2014
First submitted
19 Feb 2008
Last updated
25 Sep 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing radiation therapy, therapeutic conventional surgery and etoposide in people with Ewing Sarcoma of Bone and Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, run by Children's Oncology Group 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 40 inclusion and 0 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 25 Sep 2014. 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 10 Feb 2014). 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?

Incidence of Death (time frame: Length of protocol therapy (up to 37 weeks) plus 30 days). 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 NCT00618813.

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 25 Sep 2014.

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