Trial record 2 of 20 for:    "dermatofibrosarcoma protuberans"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00084630
First received: June 10, 2004
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Adult Fibrosarcoma
Dermatofibrosarcoma Protuberans
Recurrent Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Drug: imatinib mesylate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Imatinib (NSC-716051) in Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (confirmed complete and confirmed partial response) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
  • Frequency and severity of toxicity as assessed by NCI CTCAE version 3.0 [ Time Frame: Up to 5 years after completion of treatment ] [ Designated as safety issue: Yes ]
  • Relationship between PDGFB and survival [ Time Frame: At baseline and at the time of progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between PDGFB and tumor response to imatinib mesylate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2004
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (imatinib mesylate)
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
Given orally
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the response rate (confirmed complete and confirmed partial response) in patients with locally advanced or metastatic dermatofibrosarcoma protuberans (DFSP) treated with imatinib.

II. To estimate the one-year progression-free survival probability in this population when treated with imatinib.

III. To evaluate the frequency and severity of toxicities associated with this treatment.

IV. To measure the presence of PDGFB gene rearrangement in DFSP detectable by RT-PCR (for COL1A1-PDGFB fusions) and/or FISH (PDGFB rearrangements with unknown partners) and explore relationships between these measures and survival and tumor response in a preliminary manner.

V. To investigate in a preliminary fashion the correlation of plasma levels of imatinib after 1 month of treatment with the response of DFSP.

VI. To obtain tumor material for additional future correlative studies of the activity of intracellular kinases, cDNA microarray analyses and PDGFB receptor gene sequence analyses.

OUTLINE:

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.

Patients are followed every 6 months for 2 years and then annually for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Patients with known CNS metastases are not eligible
  • Pregnant or nursing women may not participate on this study; there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with imatinib; male/female patients of reproductive potential must also agree to employ an effective contraceptive barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patients registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study have been entered into the database
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084630

Locations
United States, Texas
Southwest Oncology Group
San Antonio, Texas, United States, 78245
Sponsors and Collaborators
Investigators
Principal Investigator: Scott Schuetze Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00084630     History of Changes
Other Study ID Numbers: NCI-2012-03184, S0345, U10CA032102, CDR0000365465
Study First Received: June 10, 2004
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dermatofibrosarcoma
Fibrosarcoma
Sarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014