Imatinib Mesylate in Treating Patients With Locally Recurrent or Metastatic Dermatofibrosarcoma Protuberans

NCT00084630 | Completed Phase 2

• 4 other identifiers: NCI-2012-03184S0345U10CA032102CDR0000365465
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well imatinib mesylate works in treating patients with locally recurrent or metastatic dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP (a type of soft tissue sarcoma). Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Conditions

Adult Fibrosarcoma; Dermatofibrosarcoma Protuberans; Recurrent Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (4)

• Response rate (confirmed complete and confirmed partial response)

  Up to 5 years

• Progression-free survival

  At 1 year

• Frequency and severity of toxicity as assessed by NCI CTCAE version 3.0

  Up to 5 years after completion of treatment

• Relationship between PDGFB and survival

  At baseline and at the time of progression

Secondary Outcomes (1)

• Relationship between PDGFB and tumor response to imatinib mesylate

  Up to 5 years

Study Arms (1)

Treatment (imatinib mesylate)

EXPERIMENTAL

Patients receive oral imatinib mesylate once daily on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with documented tumor progression and no serious side effects may continue therapy at a higher dose for another 6 courses.

Drug: imatinib mesylate; Other: laboratory biomarker analysis

Interventions

imatinib mesylate DRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec

Treatment (imatinib mesylate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (imatinib mesylate)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed diagnosis of either dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP; patients with transformed fibrosarcomatous DFSP may have primary, locally recurrent or metastatic disease; patients with DFSP must have locally recurrent or metastatic disease OR primary disease for which complete excision with a wide margin (\> 1-2 cm) would result in unacceptable cosmetic disfigurement or functional impairment
• Patients must have measurable disease; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed
• Pathology materials must be submitted for review; failure to submit pathology materials will render the patient ineligible
• Patients must be willing to have blood samples submitted for testing of drug levels; also, it is strongly recommended that patients submit fresh/frozen tumor tissue that will yield 0.5 grams (0.5 cubic centimeters) for molecular correlative studies related to the PDGFR pathway
• Patient must not have had chemotherapy, biologic therapy or investigational agents for this tumor within 28 days prior to registration
• Patients may have received prior major surgery for this disease; at least 14 days must have elapsed since the surgery and the patient must have recovered from all side effects associated with surgery; biopsy of dermatofibrosarcoma protuberans is not considered major surgery and a 14-day delay after biopsy is not required
• Prior radiotherapy is allowed, provided at least four weeks have elapsed since the last treatment, there is evidence of progressive disease within or measurable disease outside of the radiation field, and the patient must have recovered from all associated toxicities at the time of registration
• Patients must have Zubrod performance status of =\< 2
• WBC \>= 2,000/uL
• ANC \>= 1,500/uL
• Platelets \>= 100,000/uL
• Serum bilirubin =\< 1.5 x institutional upper limit of normal (IULN)
• Serum transaminase (SGOT or SGPT) must be =\< 2.5 x IULN
• Serum albumin must be \>= 2.5 mg/dl
• Patients must not be taking therapeutic doses of coumadin (Warfarin) at the time of registration; patients requiring therapeutic anticoagulation may use heparin, low molecular weight heparin or other agents; mini-dose coumadin (1 mg orally every day as prophylaxis is allowed

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Fibrosarcoma; Dermatofibrosarcoma; Sarcoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

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

• Scott Schuetze

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: May 1, 2004
• Primary Completion: July 1, 2007
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

US (1)