Trial record 8 of 189 for:    "Ewing sarcoma"

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00618813
First received: February 19, 2008
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Ewing Sarcoma of Bone
Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Other: radiation therapy
Other: therapeutic conventional surgery
Drug: etoposide
Drug: ifosfamide
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: vincristine sulfate
Drug: topotecan hydrochloride
Biological: filgrastim

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Incidence of Death [ Time Frame: Length of protocol therapy Plus 30 days ] [ Designated as safety issue: Yes ]
    Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy

  • Incidence Rate of Dose-limiting Toxicity (DLT) - Enrollment to Week 12 [ Time Frame: Enrollment to week 12 ] [ Designated as safety issue: Yes ]
    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.

  • Incidence Rate of Dose-limiting Toxicity (DLT) - Week 13 to Week 22 [ Time Frame: Week 13 to week 22 ] [ Designated as safety issue: Yes ]
    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.

  • Incidence Rate of Dose-limiting Toxicity (DLT) - Week 23 to Week 28 [ Time Frame: Week 23 to week 28 ] [ Designated as safety issue: Yes ]
    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.

  • Incidence Rate of Dose-limiting Toxicity (DLT) - Week 29-week 37 [ Time Frame: week 29-week 37 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Event Free Survival [ Time Frame: From enrollment to event or 10 years from enrollment, whichever occurs first ] [ Designated as safety issue: No ]
    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.


Enrollment: 35
Study Start Date: March 2008
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (combination chemotherapy)
See Detailed Description
Other: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: therapeutic conventional surgery
Undergo surgery
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: ifosfamide
Given IV
Other Names:
  • Cyfos
  • Holoxan
  • IFF
  • IFX
  • IPP
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: topotecan hydrochloride
Given IV
Other Names:
  • hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • TOPO
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618813

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Leo Mascarenhas Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00618813     History of Changes
Other Study ID Numbers: AEWS07P1, NCI-2009-00371, CDR0000586282, U10CA098543, COG-AEWS07P1
Study First Received: February 19, 2008
Results First Received: December 17, 2013
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma, Ewing
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Cyclophosphamide
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Doxorubicin
Etoposide
Vincristine
Topotecan
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014