Know Cancer

or
forgot password

Phase II Trial of Gleevec (Formerly Known as STI571) in Patients With Soft Tissue and Bone Sarcomas: A Multi-Disciplinary Trial of the North American Sarcoma Study Group of the Connective Tissue Oncology Society


Phase 2
10 Years
N/A
Not Enrolling
Both
Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma

Thank you

Trial Information

Phase II Trial of Gleevec (Formerly Known as STI571) in Patients With Soft Tissue and Bone Sarcomas: A Multi-Disciplinary Trial of the North American Sarcoma Study Group of the Connective Tissue Oncology Society


OBJECTIVES:

- Determine the efficacy of imatinib mesylate, as measured by response rate, in patients
with metastatic or unresectable locally advanced soft tissue or bone sarcoma who have
failed one or more prior treatment regimens.

- Determine the clinical and laboratory toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease subtype.

Patients receive oral imatinib mesylate twice daily. Treatment continues for 1 year in the
absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 60-120 patients (6-12 per stratum) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed metastatic or unresectable locally advanced
(stage IV or recurrent) soft tissue or bone sarcoma

- Eligible subtypes:

- Ewing's family (e.g., primitive neuroectodermal tumor)

- Osteosarcoma

- Synovial sarcoma

- Rhabdomyosarcoma (e.g., alveolar, embryonal, or pleomorphic)

- Liposarcoma (all variants)

- Malignant fibrous histiocytoma

- Peripheral nerve sheath (e.g., malignant peripheral nerve sheath tumor,
neurofibrosarcoma, or schwannoma)

- Fibrosarcoma

- Angiosarcoma (all variants)

- Failed standard therapy with no available salvage regimens

- Unidimensionally measurable target lesions by x-ray, CT scan, MRI, PET, or physical
examination

- Must be outside prior irradiation fields or have documented disease progression
at least 6 weeks after completion of prior radiotherapy

PATIENT CHARACTERISTICS:

Age:

- 10 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 3 times upper limit of normal (ULN)

- ALT and AST less than 2.5 times ULN

Renal:

- Creatinine less than 1.5 times ULN

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for at least 1
week after study participation for female patients and for at least 3 months after
study participation for male patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- No hormonal birth control

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- At least 28 days since any prior systemic therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Lee J. Helman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000069239

NCT ID:

NCT00031915

Start Date:

June 2002

Completion Date:

May 2007

Related Keywords:

  • Childhood Malignant Fibrous Histiocytoma of Bone
  • Sarcoma
  • metastatic osteosarcoma
  • recurrent childhood rhabdomyosarcoma
  • recurrent osteosarcoma
  • embryonal childhood rhabdomyosarcoma
  • alveolar childhood rhabdomyosarcoma
  • pleomorphic childhood rhabdomyosarcoma
  • metastatic childhood soft tissue sarcoma
  • recurrent childhood soft tissue sarcoma
  • childhood fibrosarcoma
  • childhood synovial sarcoma
  • childhood liposarcoma
  • childhood alveolar soft-part sarcoma
  • childhood neurofibrosarcoma
  • childhood angiosarcoma
  • childhood malignant fibrous histiocytoma of bone
  • previously treated childhood rhabdomyosarcoma
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • fibrosarcomatous osteosarcoma
  • Histiocytoma
  • Fibrosis
  • Osteosarcoma
  • Histiocytoma, Benign Fibrous
  • Histiocytoma, Malignant Fibrous
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Washington Hospital CenterWashington, District of Columbia  20010