NCT00085475

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

3 years

First QC Date

June 10, 2004

Last Update Submit

September 20, 2012

Conditions

Sarcoma

Keywords

recurrent adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcomaadult fibrosarcomaadult malignant fibrous histiocytoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free rate at 14 weeks

Secondary Outcomes (5)

  • Response rate as assessed by RECIST criteria

  • Progression-free survival

  • Overall survival

  • Duration of response

  • Toxicity as assessed by CTC 3.0

Interventions

imatinib mesylateDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed dermatofibrosarcoma protuberans or giant cell fibroblastoma * Locally advanced or metastatic disease * Measurable disease * Not amenable to surgery, radiotherapy, or combined modality therapy with curative intent * Documented progressive disease within the past 3 months * Previously irradiated lesions must show disease progression * Tumor expressing COL1A1/PDGF-beta by fluorescence in situ hybridization * Translocation t(17;22)(q22;q13) * No prior chemotherapy OR previously treated with 1, and only 1, line of combination chemotherapy with ifosfamide and doxorubicin OR 2 lines of single-agent therapy OR relapsed within 6 months after adjuvant chemotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 mg/dL\* NOTE: \*Transfusion allowed Hepatic * SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present) * Bilirubin ≤ 1.5 times ULN * No uncontrolled hepatic disease Renal * Creatinine ≤ 1.5 times ULN * No uncontrolled renal disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * HIV negative * No uncontrolled diabetes * No active or uncontrolled infection * No concurrent severe or uncontrolled medical disease * No medical, psychological, familial, sociological, or geographical condition that would preclude study participation, compliance, or giving informed consent * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * More than 28 days since prior biologic therapy * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) * No concurrent anticancer biologic agents Chemotherapy * See Disease Characteristics * More than 28 days since prior chemotherapy * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 6 months since prior radiotherapy * No concurrent radiotherapy * Concurrent palliative radiotherapy allowed provided radiotherapy will not be administered to a target lesion Surgery * Not specified Other * More than 28 days since prior investigational drugs * No concurrent therapeutic anticoagulation therapy with warfarin * Concurrent low-molecular weight heparin or mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed * No other concurrent anticancer agents * No other concurrent investigational drugs * No other concurrent cytostatic agents * No other concurrent tyrosine kinase inhibitors

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

Sponsors & Collaborators

Study Sites (7)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Christie Hospital NHS Trust

Manchester, England, M20 4BX, United Kingdom

Location

Related Publications (1)

  • Rutkowski P, Van Glabbeke M, Rankin CJ, Ruka W, Rubin BP, Debiec-Rychter M, Lazar A, Gelderblom H, Sciot R, Lopez-Terrada D, Hohenberger P, van Oosterom AT, Schuetze SM; European Organisation for Research and Treatment of Cancer Soft Tissue/Bone Sarcoma Group; Southwest Oncology Group. Imatinib mesylate in advanced dermatofibrosarcoma protuberans: pooled analysis of two phase II clinical trials. J Clin Oncol. 2010 Apr 1;28(10):1772-9. doi: 10.1200/JCO.2009.25.7899. Epub 2010 Mar 1.

    PMID: 20194851BACKGROUND

MeSH Terms

Conditions

SarcomaFibrosarcomaHistiocytoma, Malignant Fibrous

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Fibrous TissueNeoplasms, Connective TissueHistiocytoma

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Allan T. van Oosterom, MD, PhD

    University Hospital, Gasthuisberg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

April 1, 2004

Primary Completion

April 1, 2007

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

FR(2)NL(2)GB(1)BE(2)