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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00072280
Recruitment Status : Terminated (Due to poor accrual)
First Posted : November 6, 2003
Results First Posted : November 26, 2013
Last Update Posted : September 30, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.


Condition or disease Intervention/treatment Phase
Sarcoma Biological: dactinomycin Drug: cyclophosphamide Drug: etoposide Drug: ifosfamide Drug: vincristine sulfate Procedure: Conventional Surgery Biological: MESNA (mercaptoethane sulfonate) Biological: Filgrastim Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Phase II Study for Children With Infantile Fibrosarcoma
Study Start Date : November 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chemotherapy plus possible surgery

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
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
Other Names:
  • DACT
  • Actinomycin-D
  • Cosmegen
  • NSC #3053

Drug: cyclophosphamide
Given IV over 60 minutes, dose 25 mg/kg on days 1,22,43 and 64.
Other Names:
  • Cytoxan
  • NSC #26271

Drug: etoposide
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.
Other Names:
  • ETOP
  • VePesid
  • Etopophos
  • VP-16
  • NSC #141540

Drug: ifosfamide
Given IV over 1 hour, dose 60mg/kg in D5 1/4 NS 10 cc/kg IV on days 1-5 of IE Cycle
Other Names:
  • Isophosphamide
  • Iphosphamide
  • Z4942
  • Ifex
  • NSC #109724

Drug: vincristine sulfate
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
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574

Procedure: Conventional Surgery
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.

Biological: MESNA (mercaptoethane sulfonate)
Given orally. Oral daily MESNA dose is equal to at least 60% of the daily cyclophosphamide dose.
Other Names:
  • Sodium 2-mercaptoethane sulfonate
  • UCB 3983
  • Mesnex
  • NSC #113891

Biological: Filgrastim
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
Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-CSF
  • Neupogen
  • NSC #614629

Experimental: Surgery only
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
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.




Primary Outcome Measures :
  1. Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm [ Time Frame: Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years) ]
    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).



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072280


  Show 74 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Mignon Loh, MD University of California, San Francisco
Study Chair: Anne B. Warwick, MD, MPH Medical College of Wisconsin

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00072280     History of Changes
Other Study ID Numbers: ARST03P1
CDR0000339565 ( Other Identifier: PDQ (Physician Data Query) )
NCI-2012-02561 ( Other Identifier: NCI )
COG-ARST03P1 ( Other Identifier: Children's Oncology Group )
First Posted: November 6, 2003    Key Record Dates
Results First Posted: November 26, 2013
Last Update Posted: September 30, 2014
Last Verified: September 2014

Keywords provided by Children's Oncology Group:
childhood fibrosarcoma
nonmetastatic childhood soft tissue sarcoma

Additional relevant MeSH terms:
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Sarcoma
Fibrosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Dactinomycin
Cyclophosphamide
Ifosfamide
Isophosphamide mustard
Etoposide
Vincristine
Lenograstim
Sargramostim
Mesna
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Tubulin Modulators