Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma

NCT00072280 | Terminated Phase 2 Results DMC

• 4 other identifiers: ARST03P1CDR0000339565NCI-2012-02561COG-ARST03P1
• Study Type: interventional
• Target: 7
• Locations: 4 countries
• Sites: 74

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well surgery and/or combination chemotherapy work in treating children with fibrosarcoma.

Conditions

Sarcoma

Keywords

childhood fibrosarcoma; nonmetastatic childhood soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

• Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm

  Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).

  Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)

Study Arms (2)

Chemotherapy plus possible surgery

EXPERIMENTAL

Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.)

Biological: dactinomycin; Drug: cyclophosphamide; Drug: etoposide; Drug: ifosfamide; Drug: vincristine sulfate; Procedure: Conventional Surgery; Biological: MESNA (mercaptoethane sulfonate); Biological: Filgrastim

Surgery only

EXPERIMENTAL

Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.

Procedure: Conventional Surgery

Interventions

dactinomycin BIOLOGICAL

Given Slow intravenous (IV) push over 1-5 minutes, dose \< 1yr 0.025 mg/kg \> or = 1 yr 0.045 mg/kg (max dose 2.5 mg) on days 1,22,43 and 64

Also known as: DACT, Actinomycin-D, Cosmegen, NSC #3053

Chemotherapy plus possible surgery

cyclophosphamide DRUG

Given IV over 60 minutes, dose 25 mg/kg on days 1,22,43 and 64.

Also known as: Cytoxan, NSC #26271

Chemotherapy plus possible surgery

etoposide DRUG

Given IV over 1 hour, dose 3.3 mg/kg in normal saline (NS) 10 cc/kg (or to equal 0.4 mg/mL concentration) on days 1-5 of IE cycle.

Also known as: ETOP, VePesid, Etopophos, VP-16, NSC #141540

Chemotherapy plus possible surgery

ifosfamide DRUG

Given IV over 1 hour, dose 60mg/kg in D5 1/4 NS 10 cc/kg IV on days 1-5 of IE Cycle

Also known as: Isophosphamide, Iphosphamide, Z4942, Ifex, NSC #109724

Chemotherapy plus possible surgery

vincristine sulfate DRUG

Given IV Push over 1 minute, dose 0.05 mg/kg (max dose 2 mg) on days 1,8,15,22,29,36,43,50,57 and 64

Also known as: Oncovin, VCR, LCR, NSC #67574

Chemotherapy plus possible surgery

Conventional Surgery PROCEDURE

Applied only when lesion is resectable. Surgery is the primary means of local control in this study and reasonable attempts at achieving clear margins with an "envelope" of normal tissue should be undertaken at the initial and/or subsequent resections.

Chemotherapy plus possible surgery; Surgery only

MESNA (mercaptoethane sulfonate) BIOLOGICAL

Given orally. Oral daily MESNA dose is equal to at least 60% of the daily cyclophosphamide dose.

Also known as: Sodium 2-mercaptoethane sulfonate, UCB 3983, Mesnex, NSC #113891

Chemotherapy plus possible surgery

Filgrastim BIOLOGICAL

Given IV - Only use filgrastim if chemotherapy has been delayed or modified for hematologic toxicity, or if patient experiences a significant life-threatening toxicity due to bone marrow suppression

Also known as: Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen, NSC #614629

Chemotherapy plus possible surgery

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * Histologically confirmed infantile, congenital, or pediatric fibrosarcoma * Initial biopsy or surgery performed within the past 35 days * No evidence of distant metastases * Available tissue for central review PATIENT CHARACTERISTICS: Age * Under 2 at diagnosis Performance status * Zubrod Score (ECOG) Life expectancy * At least 8 weeks Hematopoietic * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3\* * Hemoglobin at least 10.0 g/dL\* NOTE: \*Transfusions allowed Hepatic * Total bilirubin no greater than 1.5 times upper limit of normal (ULN) (patients over 4 weeks of age) * Patients under 4 weeks of age with an indirect hyperbilirubinemia are eligible, provided the following criteria are met: * At least 2 bilirubin values at separate timepoints show a decrease in measurement * Direct bilirubin is no greater than 20% of the total bilirubin * Direct bilirubin no greater than 1.5 times ULN * Alanine Aminotransferase (ALT) less than 2.5 times ULN Renal * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min PRIOR/CONCURRENT THERAPY: Biologic therapy * No concurrent sargramostim (GM-CSF) Chemotherapy * No prior chemotherapy * No other concurrent anticancer chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior or concurrent radiotherapy except emergent radiotherapy for impending tracheal compression Surgery * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (74)

Phoenix Children's Hospital

Phoenix, Arizona, 85016-7710, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242-2814, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Long Beach, California, 90801, United States

Location

Kaiser Permanente Medical Center - Oakland

Sacramento, California, 95825, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Stanford Comprehensive Cancer Center - Stanford

Stanford, California, 94305, United States

Location

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

Farmington, Connecticut, 06360-2875, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Lee Cancer Care of Lee Memorial Health System

Fort Myers, Florida, 33901, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Sacred Heart Cancer Center at Sacred Heart Hospital

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

St. Joseph's Cancer Institute at St. Joseph's Hospital

Tampa, Florida, 33607, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

MBCCOP - Medical College of Georgia Cancer Center

Augusta, Georgia, 30912-3730, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40232, United States

Location

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

CancerCare of Maine at Eastern Maine Medial Center

Bangor, Maine, 04401, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Spectrum Health Hospital - Butterworth Campus

Grand Rapids, Michigan, 49503-2560, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Children's Hospitals and Clinics of Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota Medical Center & Children's Hospital - Fairview

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Overlook Hospital

Morristown, New Jersey, 07962, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106-5000, United States

Location

Columbus Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Children's Medical Center - Dayton

Dayton, Ohio, 45404-1815, United States

Location

Tod Children's Hospital - Forum Health

Youngstown, Ohio, 44501, United States

Location

OU Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-9786, United States

Location

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Greenville Hospital System Cancer Center

Greenville, South Carolina, 29605, United States

Location

East Tennessee Children's Hospital

Knoxville, Tennessee, 37916, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6310, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 77030-2399, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229-3993, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113-1100, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99220-2555, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Westmead Institute for Cancer Research at Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Women's and Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 1Z2, Canada

Location

Children's & Women's Hospital of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Starship Children's Health

Auckland, 1, New Zealand

Location

MeSH Terms

Conditions

Sarcoma; Fibrosarcoma

Interventions

Dactinomycin; Cyclophosphamide; Etoposide; etoposide phosphate; Ifosfamide; Vincristine; Mesna; Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Carbohydrates; Oxazines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Indolizidines; Indolizines; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors

Limitations and Caveats

Study closed early due to slow accrual. Analysis plans were not carried out (lack of statistical precision compromised the ability to draw appropriate conclusions). Reported Primary Outcome Measure data reflects data collection through March 2008.

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

626-447-0064

Study Officials

• Mignon Loh, MD

  University of California, San Francisco

  STUDY CHAIR

• Anne B. Warwick, MD, MPH

  Medical College of Wisconsin

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: November 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 30, 2014
• Results First Posted: November 26, 2013

Record last verified: 2014-09

Locations

US (64); CA (7); AU (2); NZ (1)