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Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma


OBJECTIVES:

Primary

- Determine the response rate (confirmed complete response and partial response) in
patients with HER2/neu-overexpressing locally advanced or metastatic synovial sarcoma
treated with trastuzumab (Herceptin^®).

Secondary

- Determine the frequency and severity of toxic effects of this drug in these patients.

- Determine overall survival and progression-free survival of patients treated with this
drug.

- Correlate, preliminarily, SYT-SSX translocation, HER2/neu expression, and monophasic
and biphasic phenotype with clinical outcomes in patients treated with this drug.

OUTLINE: This is a pilot, multicenter study.

Patients receive trastuzumab (Herceptin^®) IV over 90 minutes on day 1. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 weeks until disease
progression and then every 6 months for up to 2 years from study entry.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-40
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed synovial sarcoma meeting 1 of the following stage criteria:

- Locally advanced disease, defined as 1 of the following:

- Incurable by conventional multidisciplinary therapy, including surgery

- Surgically resectable only with significant morbidity

- Metastatic disease

- Tumor HER2/neu positive (2+ or 3+) by immunohistochemistry

- Tumor tissue must be available AND patient must be willing to allow specimen
submission

- Measurable disease

- No known CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 1,000/mm^3

- Hemoglobin > 8 g/dL

- Platelet count > 100,000/mm^3

Hepatic

- Bilirubin < 1.5 times upper limit of normal (ULN)

- SGOT and/or SGPT < 1.5 times ULN (5 times ULN if liver metastases are present)

Renal

- Creatinine < 1.5 times ULN OR

- Creatinine clearance > 60 mL/min

Cardiovascular

- LVEF > 45% by MUGA

Gastrointestinal

- No active peptic ulcer disease

- No active gastrointestinal bleeding

- No active inflammatory bowel disease

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No known HIV positivity

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent filgrastim (G-CSF)

Chemotherapy

- At least 3 weeks since prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- At least 60 days since prior radiotherapy to the target lesion*

- No concurrent radiotherapy NOTE: *Lesion must have demonstrated disease progression
after completion of therapy

Surgery

- At least 21 days since prior major surgery and recovered

Other

- At least 60 days since prior embolization or radiofrequency ablation to the target
lesion* NOTE: *Lesion must have demonstrated disease progression after completion of
therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate (confirmed complete response and partial response)

Safety Issue:

No

Principal Investigator

Ernest C. Borden, MD

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000413703

NCT ID:

NCT00104949

Start Date:

July 2005

Completion Date:

August 2007

Related Keywords:

  • Sarcoma
  • adult synovial sarcoma
  • recurrent adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma, Synovial
  • Sarcoma

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