Imatinib Mesylate in Treating Patients With Salivary Gland Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00045669
First received: September 6, 2002
Last updated: June 11, 2012
Last verified: June 2012

September 6, 2002
June 11, 2012
July 2002
January 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00045669 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have unresectable and/or metastatic salivary gland cancer.

OBJECTIVES:

  • Determine the antitumor activity of imatinib mesylate, in terms of objective response rates (partial and complete responses) and duration of overall response, in patients with unresectable and/or metastatic adenoid cystic, lymphoepithelioma-like, or myoepithelial salivary gland cancer.
  • Determine the safety and tolerability of this drug in these patients.
  • Correlate the activity of c-kit and downstream kinases in pre- and post-treatment tumoral biopsies with clinical course in patients treated with this drug.
  • Determine the effect of treatment with this drug on tumor samples from these patients in terms of proliferation, apoptosis, and angiogenesis.
  • Correlate the steady state levels of this drug achieved with clinical and laboratory correlative endpoints in these patients.
  • Determine whether early changes in metabolic activity correlate with molecular changes and predict outcome to therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate twice daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive treatment for up to 6 months.

Patients are followed within 3 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
Drug: imatinib mesylate
Not Provided
Hotte SJ, Winquist EW, Lamont E, MacKenzie M, Vokes E, Chen EX, Brown S, Pond GR, Murgo A, Siu LL. Imatinib mesylate in patients with adenoid cystic cancers of the salivary glands expressing c-kit: a Princess Margaret Hospital phase II consortium study. J Clin Oncol. 2005 Jan 20;23(3):585-90.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
January 2005
January 2004   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenoid cystic, lymphoepithelioma-like, or myoepithelial salivary gland cancer

    • Unresectable AND/OR
    • Radiologically documented metastatic disease
  • c-kit positive tumor (1+, 2+, or 3+)
  • At least 1 unidimensionally measurable lesion

    • More than 20 mm by conventional techniques OR
    • More than 10 mm by spiral CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 12 weeks

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3

Hepatic

  • Bilirubin less than 1.25 times upper limit of normal (ULN)
  • AST/ALT less than 2.5 times ULN

Renal

  • Creatinine less than 1.25 times ULN OR
  • Creatinine clearance greater than 50 mL/min

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina
  • No active cardiomyopathy
  • No unstable ventricular arrhythmias
  • No uncontrolled hypertension

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study
  • No other active malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or non-melanomatous skin cancer
  • No uncontrolled psychotic disorders
  • No serious infections
  • No active peptic ulcer disease
  • No other serious medical condition that would preclude study
  • No prior allergy to compounds of similar chemical or biologic composition as imatinib mesylate

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent filgrastim (G-CSF)

Chemotherapy

  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy to sites of measurable disease

Surgery

  • At least 4 weeks since prior surgery and recovered

Other

  • No other concurrent investigational agents
  • No concurrent therapeutic warfarin

    • Mini-dose warfarin for prophylaxis or low-molecular weight heparin allowed
  • No concurrent erythromycin
  • No concurrent acetaminophen doses exceeding 3 g/day
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
NCT00045669
CDR0000257029, PMH-PHL-009, NCI-5663
Not Provided
University Health Network, Toronto
University Health Network, Toronto
National Cancer Institute (NCI)
Study Chair: George P. Browman, MD Margaret and Charles Juravinski Cancer Centre
University Health Network, Toronto
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP