AzTrials
AzTrials

SarcomaPhase 2NCT00002804

Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma

A Phase 2 study testing filgrastim, doxorubicin hydrochloride and ifosfamide in people with Sarcoma, run by Children's Oncology Group at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Sarcoma
What is being tested?
filgrastim, doxorubicin hydrochloride and ifosfamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
9 sitesin 3 countries
Study dates
Sep 1996to Apr 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS: Biopsy proven non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) Evaluable residual tumor after initial biopsy or excision required Registration required within 42 days of definitive diagnosis Grade II/III, unresectable or metastatic disease The following histologies exclude: Angiofibroma of the nasopharynx Mesothelioma Desmoid tumor Peripheral neuroepithelioma Desmoplastic small cell tumor Rhabdomyosarcoma Extraosseous Ewing's sarcoma Undifferentiated sarcoma Kaposi's sarcoma Grade 1 NRSTS, including: Angiomatoid malignant fibrous histiocytoma Dermatofibrosarcoma protuberans Myxoid and well-differentiated liposarcoma Well-differentiated and infantile hemangiopericytoma Well-differentiated malignant peripheral nerve sheath tumor

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine normal for age No hydronephrosis Cardiovascular: Shortening fraction greater than 28% Other: No HIV infection Not pregnant or nursing Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy No prior nephrectomy (surgical correction of hydronephrosis allowed)

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

United States7 sites

  • Cancer Center, University of Virginia HSC

    Charlottesville, Virginia, 22908

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • San Antonio Military Pediatric Cancer and Blood Disorders Center

    Lackland Air Force Base, Texas, 78236-5300

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2794

  • MBCCOP - LSU Medical Center

    New Orleans, Louisiana, 70112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

Other trials in United States

Puerto Rico1 site

  • University of Puerto Rico School of Medicine Medical Sciences Campus

    San Juan, 00936-5067

Other trials in Puerto Rico

Switzerland1 site

  • Clinique de Pediatrie

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: Phase II Study of Neoadjuvant Vincristine, Ifosfamide, Doxorubicin, and AND G-CSF in Children With Advanced Stage Non-Rhabdomyosarcoma Soft Tissue Sarcomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, surgery, and radiation therapy in treating children who have advanced soft tissue sarcoma.

Read the detailed description

OBJECTIVES: I. Assess the response to vincristine/ifosfamide/doxorubicin (VID) with granulocyte colony-stimulating factor support in children with newly diagnosed, inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas. II. Estimate the 2-year and event-free survival rates in children treated with VID plus radiotherapy and/or surgery. III. Establish a bank of frozen tumor and peripheral blood tissue for use in further molecular studies.

OUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 Mesna Mercaptoethane sulfonate, NSC-113891 VCR Vincristine, NSC-67574 VID VCR/IFF/DOX Induction: 3-Drug Combination Chemotherapy. VID. Local Control: Surgery and/or Radiotherapy plus 3-Drug Combination Chemotherapy. Excision of the primary tumor and pulmonary metastases; and/or irradiation of the primary tumor and pulmonary metastases using x-rays or Co60 beam energies of at least 4 MV (electrons or iridium-192 implant allowed for boost); plus VID. Continuation: 3-Drug Combination Chemotherapy. VID.

PROJECTED ACCRUAL: A total of 40 patients will be entered over 2.7 years if there are at least 7 responses in the first 20 patients.

Conditions
Sarcoma
Keywords
nonmetastatic childhood soft tissue sarcoma, metastatic childhood soft tissue sarcoma
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • filgrastimBiological

    Also called Granulocyte-Colony Stimulating Factor, Neupogen, G-CSF

  • doxorubicin hydrochlorideDrug

    Also called Adriamycin, NSC#123127

  • ifosfamideDrug

    Also called Isophosphamide, IFEX

  • mesnaDrug

    Also called Sodium 2-Mercaptoethane Sulfonate, Mesnex, Urimetexan, NSC#113891

  • vincristine sulfateDrug

    Also called VCR, Oncovin, NSC#67574

  • conventional surgeryProcedure or surgery

  • brachytherapyRadiation

  • low-LET cobalt-60 gamma ray therapyRadiation

  • low-LET electron therapyRadiation

  • low-LET photon therapyRadiation

Study groups in NCT00002804
Study groupRoleWhat they receive
Chemotherapy RegimenExperimentalInduction (Weeks 1-6) Vincristine sulfate (1.5 mg/m2) day 1, Ifosfamide (3 grams/m2) days 1-3, Doxorubicin (30 mg/m2) days 1-2, filgrastim day 4. Weeks 2 and 3 - Vincristine sulfate (1.5 mg/m2) IV day 1, week 5 no chemotherapy. Evaluate for response. Local Control (Weeks 7-13) Conventional surgery and radiation therapy. Vincristine sulfate (1.5 mg/m2) IV day 1, Ifosfamide (3 grams/m2) days 1-3, Doxorubicin (30 mg/m2) days 1-2, filgrastim day 4. Treatment continues per protocol.
Receives: Biological: filgrastim; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Drug: mesna; Drug: vincristine sulfate; Procedure: conventional surgery; Radiation: brachytherapy; Radiation: low-LET cobalt-60 gamma ray therapy; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate the response rate to the combination of vincristine, ifosfamide, and doxorubicin (VID), with G-CSF support

    To estimate the response rate to the combination of vincristine, ifosfamide, and doxorubicin (VID), with G-CSF support, in children with newly diagnosed inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas.

Secondary outcomes (2)

  1. Event-free Survival

    To estimate the 2-year survival and event-free survival of children treated with VID in combination with radiotherapy and/or surgery

  2. Establish a bank of frozen tissue (tumor and peripheral blood)

    To establish a bank of frozen tissue (tumor and peripheral blood) for use in further molecular studies.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2004 (estimated)
  2. Study startSep 1996
  3. Primary completionJun 2000
  4. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002804
Sponsor's protocol ID
9553
Other IDs
POG-9553, CDR0000064905, COG-P9953
Status last verified
Jul 2014
First submitted
1 Nov 1999
Last updated
25 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, doxorubicin hydrochloride and ifosfamide in people with Sarcoma, run by Children's Oncology Group at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Puerto Rico, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the response rate to the combination of vincristine, ifosfamide, and doxorubicin (VID), with G-CSF support. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in