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


Phase 1/Phase 2
16 Years
N/A
Not Enrolling
Both
Refractory Desmoplastic Small Round Cell Tumors

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Trial Information

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

Inclusion Criteria


Inclusion criteria:

1. Patients > 16 years of age.

2. Histologically documented diagnosis of DSRCT, unresponsive or in no complete
remission after any conventional multimodality approach.

3. Immunohistochemical documentation of activated PDGF-R expression by tumor

4. At least one measurable site of disease

5. Performance status 0,1, 2 or 3 (Eastern Cooperative Oncology Group)

6. Adequate end organ function

Exclusion criteria:

1. Patient has received any other investigational agents within 28 days of first day of
study drug dosing, unless the disease is rapidly progressing.

2. Patient is < 5 years free of another primary malignancy

3. Patient with congestive heart failure or myocardial infarction within 6 months of
study

4. Female patients who are pregnant or breast-feeding.

5. Severe and/or uncontrolled medical disease

6. Known brain metastasis.

7. Chronic active hepatitis or cirrhosis

8. Known diagnosis of human immunodeficiency virus (HIV) infection.

9. Chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly
progressing.

10. Previous radiotherapy to > 25 % of the bone marrow

11. Major surgery within 2 weeks prior to study entry.

Other protocol defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall tumor response rates

Outcome Description:

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

Outcome Time Frame:

Assessed every 3 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

Italy: Minister of Health (AIFA)

Study ID:

CSTI571BIT06

NCT ID:

NCT00417807

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Refractory Desmoplastic Small Round Cell Tumors
  • refractory desmoplastic small round cell tumors
  • PDGF-R
  • Desmoplastic Small Round Cell Tumor

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