Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

NCT00417807 | Completed Phase 1

• 1 other identifier: CSTI571BIT06
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Refractory Desmoplastic Small Round Cell Tumors

Keywords

refractory desmoplastic small round cell tumors; PDGF-R

Outcome Measures

Primary Outcomes (1)

• Overall tumor response rates

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

  Assessed every 3 months

Secondary Outcomes (4)

• Explore how Imatinib cooperated with other treatment modatilities

  Survival data was collected until death

• Safety and tolerability

  Safety data collected until patients were no longer in study

• Conversion rate to surgical resectability

  After best tumor response.

• Mutational analysis of molecular targets of imatinib (at any time during the study)

  At any time during the study

Study Arms (1)

Gleevec/Glivec

EXPERIMENTAL

Drug: Imatinib mesilate

Interventions

Imatinib mesilate DRUG

Also known as: STI571

Gleevec/Glivec

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Ivrea, Italy

Location

Novartis Investigative Site

Milan, Italy

Location

Novartis Investigative Site

Napoli, Italy

Location

Novartis Investigative Site

Padua, Italy

Location

Novartis Investigative Site

Ravenna, Italy

Location

Novartis Investigative Site

Rozzano, Italy

Location

Novartis Investigative Site

Torino, Italy

Location

Novartis Investigative Stie

Vatania, Italy

Location

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: August 1, 2005
• Primary Completion: June 1, 2009
• Last Updated: December 24, 2010

Record last verified: 2010-12

Locations

IT (8)