Completed

NCT Number: NCT00417807

Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria

Completed

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Key information

Conditions

Refractory Desmoplastic Small Round Cell Tumors

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigative Site, Ivrea, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients > 16 years of age.
Histologically documented diagnosis of DSRCT, unresponsive or in no complete remission after any conventional multimodality approach.
Immunohistochemical documentation of activated PDGF-R expression by tumor
At least one measurable site of disease
Performance status 0,1, 2 or 3 (Eastern Cooperative Oncology Group)
Adequate end organ function

Exclusion criteria

Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
Patient is < 5 years free of another primary malignancy
Patient with congestive heart failure or myocardial infarction within 6 months of study
Female patients who are pregnant or breast-feeding.
Severe and/or uncontrolled medical disease
Known brain metastasis.
Chronic active hepatitis or cirrhosis
Known diagnosis of human immunodeficiency virus (HIV) infection.
Chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
Previous radiotherapy to > 25 % of the bone marrow
Major surgery within 2 weeks prior to study entry.

Other protocol defined inclusion/exclusion criteria may apply.

Treatment and study plan

Imatinib mesilate

Drug

Other names: STI571

Primary outcomes

Overall tumor response rates

Time frame: Assessed every 3 months

An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.

Secondary outcomes

Explore how Imatinib cooperated with other treatment modatilities

Time frame: Survival data was collected until death

Recorded survival after treatment and other associated treatment modalities.
Safety and tolerability

Time frame: Safety data collected until patients were no longer in study
Conversion rate to surgical resectability

Time frame: After best tumor response.

Assessed actual resectability rate after therapy compared to resectability before therapy.
Mutational analysis of molecular targets of imatinib (at any time during the study)

Time frame: At any time during the study

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R

Important dates

Study start: 2005
Primary completion: 2009
First posted: Jan 4, 2007
Registry last updated: Dec 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.