Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00061893

Purpose

RATIONALE: Drugs used in chemotherapy, such as vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of Ewing's sarcoma by stopping blood flow to the tumor. Combining more than one chemotherapy drug with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining low-dose vinblastine and celecoxib with standard regimens of combination chemotherapy in treating patients who have newly-diagnosed metastatic Ewing's sarcoma family of tumors.

Condition	Intervention	Phase
Sarcoma	Drug: celecoxib Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: vinblastine Drug: vincristine sulfate Procedure: conventional surgery Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study of Low-Dose Antiangiogenic Chemotherapy in Combination With Standard Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma Family of Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma Surgery

Drug Information available for: Cyclophosphamide Vincristine Doxorubicin Doxorubicin hydrochloride Etoposide Etoposide phosphate Celecoxib Vinblastine sulfate Vinblastine Vincristine sulfate Ifosfamide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility as measured by toxicity at study completion [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Event-free survival at 1 to 2 years following study completion [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	April 2004
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Regimen A (surgery only): Experimental Patients will undergo surgery. They will receive combination chemotherapy during weeks 15-42. Throughout treatment, patients will receive filgrastim periodically, infusions of vinblastine two or three times a week, and celecoxib by mouth twice a day.	Drug: celecoxib Given orally Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: ifosfamide Given IV Drug: vinblastine Given IV Drug: vincristine sulfate Given IV Procedure: conventional surgery Surgery on week 13
Regimen B (radiotherapy only): Experimental Patients will undergo radiation therapy 5 days a week for up to 6 weeks. They will also receive combination chemotherapy during weeks 13-40. Throughout treatment, patients will receive filgrastim periodically, infusions of vinblastine two or three times a week, and celecoxib by mouth twice a day.	Drug: celecoxib Given orally Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: ifosfamide Given IV Drug: vinblastine Given IV Drug: vincristine sulfate Given IV Radiation: radiation therapy Radiotherapy 5 days a weeks for approximately 6 weeks.
Regimen C (surgery and radiotherapy): Experimental Patients will undergo surgery. Beginning in week 15, they may undergo radiation therapy 5 days a week for up to 6 weeks. Patients will receive infusions of combination chemotherapy during weeks 15-42. Throughout treatment, patients will receive filgrastim periodically, infusions of vinblastine two or three times a week, and celecoxib by mouth twice a day.	Drug: celecoxib Given orally Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: ifosfamide Given IV Drug: vinblastine Given IV Drug: vincristine sulfate Given IV Procedure: conventional surgery Surgery on week 13 Radiation: radiation therapy Radiotherapy 5 days a weeks for approximately 6 weeks.
Regimen D (preoperative radiotherapy): Experimental Patients will undergo radiation therapy 5 days a week for up to 6 weeks. They will receive combination chemotherapy during weeks 13-42 and undergo surgery in week 22. Throughout treatment, patients will receive filgrastim periodically, infusions of vinblastine two or three times a week, and celecoxib by mouth twice a day.	Drug: celecoxib Given orally Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: ifosfamide Given IV Drug: vinblastine Given IV Drug: vincristine sulfate Given IV Radiation: radiation therapy Radiotherapy 5 days a weeks for approximately 6 weeks.

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Eligibility

Ages Eligible for Study:	up to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed Ewing's sarcoma family of tumors of the bone or soft tissues
- Paraspinal tumors of extra-dural origin and Askin's tumor of the chest wall are eligible
Metastatic disease, defined by the following criteria:
- Lesions are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a body cavity with the primary tumor
- A single pulmonary or pleural nodule greater than 1 cm OR multiple nodules greater than 0.5 cm are considered evidence of pulmonary or pleural metastases (unless there is another clear medical explanation for these lesions)
- Contralateral pleural effusions are considered metastatic disease
No CNS involvement

PATIENT CHARACTERISTICS:

Age

50 and under (at diagnosis)

Performance status

Lansky 50-100% (under 17 years of age)
Karnofsky 50-100% (age 17 and over)
- Patients whose performance status is affected by a pathological fracture are allowed provided they are able to undergo treatment

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST or ALT less than 5 times ULN

Renal

Creatinine adjusted according to age as follows*:
- No greater than 0.4 mg/dL (≤ 5 months)
- No greater than 0.5 mg/dL (6 months -11 months)
- No greater than 0.6 mg/dL (1 year-23 months)
- No greater than 0.8 mg/dL (2 years-5 years)
- No greater than 1.0 mg/dL (6 years-9 years)
- No greater than 1.2 mg/dL (10 years-12 years)
- No greater than 1.4 mg/dL (13 years and over [female])
- No greater than 1.5 mg/dL (13 years to 15 years [male])
- No greater than 1.7 mg/dL (16 years and over [male]) OR
Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min* NOTE: *Unless these values are related to renal insufficiency secondary to tumor involvement that is expected to improve once the tumor mass is smaller (e.g., pelvic mass causing obstructive hydronephrosis)

Cardiovascular

Shortening fraction at least 27% by echocardiogram OR
Ejection fraction at least 50% by MUGA

Other

Not pregnant or nursing
Fertile patients must use effective contraception
Body surface area at least 0.4 m^2
No allergy to sulfa
No aspirin hypersensitivity
No asthma triad (asthma with nasal polyps, and urticaria)
No other prior cancer, including nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior bone marrow or stem cell transplantation

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

Not specified

Other

No other concurrent nonsteroidal anti-inflammatory medications, including salicylates
No concurrent dexrazoxane unless approved by the study investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061893

Show 101 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Judy L. Felgenhauer, MD, PS

Sacred Heart Children's Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers:	CDR0000302409, COG-AEWS02P1
Study First Received:	June 5, 2003
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00061893 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms, Connective and Soft Tissue
Sarcoma, Ewing's
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Etoposide

Alkylating Agents
Celecoxib
Neoplasms by Histologic Type
Cyclooxygenase Inhibitors
Mitosis Modulators
Osteosarcoma
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Ifosfamide
Neoplasms
Neoplasms, Bone Tissue

ClinicalTrials.gov processed this record on February 08, 2010