Thalidomide in Treating Patients With Gynecologic Sarcomas

Sarcoma Clinical Trial

Official title:

Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006005
• Other study ID #: CDR0000068013
• Secondary ID: NYGOG-99-001NCI-
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: June 20, 2013
• Start date: September 2000
• Est. completion date: August 2006

Study information

• Verified date: August 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.

Description:

OBJECTIVES:

• Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.

• Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.

• Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.

OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed sarcoma or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin not amenable to resection or radiotherapy

• Measurable disease

• Lesions accurately measured in at least 1 dimension of at least 20 mm in longest diameter with conventional techniques or at least 10 mm with helical CT scan

• Histologically or cytologically confirmed neoplastic nature if solitary lesion

• No nonmeasurable disease, defined as:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Inflammatory breast disease

• Lymphangitis cutis/pulmonis

• Unconfirmed abdominal masses not followed by imaging techniques

• Cystic lesions

• Documented recurrence or persistence following appropriate surgery, radiotherapy, and/or chemotherapy

• Postmenopausal or status post hysterectomy

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,000/mm^3

• Platelet count at least 50,000/mm^3

Hepatic:

• Bilirubin normal

• Transaminases less than 2.5 times upper limit of normal

Renal:

• Creatinine less than 1.5 mg/dL

Other:

• No grade 2 or greater peripheral neuropathy

• No medical or social factors that would preclude study, including inability to take oral medication

• No other serious illness requiring immediate therapy

• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 30 days since any prior noncytotoxic experimental antiemetic or antifungal investigational drug

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Sarcoma

Intervention

Drug:
• thalidomide

Locations

Country	Name	City	State
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	Albert Einstein Clinical Cancer Center	Bronx	New York
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	North Shore University Hospital	Manhasset	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	St. Luke's-Roosevelt Hospital Center - Roosevelt Division	New York	New York
United States	St. Vincent's Comprehensive Cancer Center	New York	New York
United States	New York Medical College	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,