Suspended

A Pilot Phase II Study for Children With Infantile Fibrosarcoma

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What is being tested

dactinomycin

+ cyclophosphamide
+ etoposide
Biological
Drug
Procedure
Who is being recruted

Fibrosarcoma
+4

+ Neoplasms
+ Neoplasms by Histologic Type
Until 2 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2004
See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the event-free and relapse-free survival of children with initially unresectable congenital, infantile, or childhood fibrosarcoma treated with neoadjuvant chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC) before definitive local control. Secondary * Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by observation after local control with positive microscopic margins. * Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by additional chemotherapy comprising etoposide and ifosfamide after local control with gross positive margins. * Determine the event-free and relapse-free survival of patients treated with surgery alone. OUTLINE: This is a pilot, multicenter study. Patients begin treatment according to lesion resectability. Patients with resectable lesions proceed to surgery. * Surgery: Patients undergo resection of disease lesions. Patients with clear or microscopically positive margins undergo observation only. Patients with grossly positive margins undergo re-resection if feasible. Patients with grossly positive margins after re-resection or for whom re-resection is not feasible receive chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC). Patients with unresectable lesions receive VAC chemotherapy. * VAC chemotherapy: Patients receive vincristine intravenously (IV) on days 1, 8, and 15 and dactinomycin IV and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2-4 courses of VAC chemotherapy proceed to chemotherapy comprising etoposide and ifosfamide (IE). Patients with stable disease after 4 courses of VAC chemotherapy proceed to IE chemotherapy. Patients with a partial response (PR) and unresectable lesions after 4 courses of VAC chemotherapy receive 2 additional courses of VAC and are then re-evaluated. Patients proceed to surgery if they continue to have a PR or achieve a complete response (CR) and lesions are now resectable. Patients with a CR or PR and resectable lesions after 4 courses of VAC chemotherapy proceed to surgery. Patients with stable disease, progressive disease, or a PR and unresectable lesions after 6 courses of VAC proceed to IE chemotherapy. * IE chemotherapy: Patients receive etoposide IV over 1 hour and ifosfamide IV over 1 hour on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with a CR or PR and resectable lesions after 2-4 courses of IE chemotherapy proceed to surgery. All patients are followed every 3 months for 6 months, every 6 months for 1 year, and then as clinically indicated. PROJECTED ACCRUAL: A total of 60-70 patients will be accrued for this study within 8 years.

Official TitleA Pilot Phase II Study for Children With Infantile Fibrosarcoma 
NCT00072280
Principal SponsorChildren's Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
7 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Until 2 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Fibrosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms, Fibrous Tissue
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.)

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

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

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.

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

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

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.

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

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
Group II
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.

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.
Study Objectives
Primary Objectives

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 74 locations
Suspended
Phoenix Children's HospitalPhoenix, United StatesSee the location
Suspended
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, United States
Suspended
Southern California Permanente Medical GroupDowney, United States
Suspended
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, United States
Suspended74 Study Centers