Interferon Alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma

NCT ID: NCT00026416

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31

Brief Summary

RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of cancer cells. Combining interferon alfa and thalidomide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa and thalidomide in treating patients who have undergone surgery for soft tissue sarcoma or bone sarcoma.

Detailed Description

OBJECTIVES:

• Determine the efficacy of interferon alfa and thalidomide, in terms of time to disease progression, in patients with surgically resected high-risk soft tissue sarcoma or bone sarcoma.
• Determine the incidence of metastatic disease and overall survival in patients treated with this regimen.
• Determine the clinical and laboratory toxic effects and the tolerability of this regimen in these patients.

OUTLINE: Patients receive interferon alfa subcutaneously three times a week on weeks 1-60 and oral thalidomide once daily on weeks 13-60 in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks for at least 2 years.

PROJECTED ACCRUAL: A total of 20-48 patients will be accrued for this study.

Conditions

Sarcoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

recombinant interferon alfa

Intervention Type: BIOLOGICAL

thalidomide

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• More than 2 months

Hematopoietic:

• WBC greater than 3,000/mm^3
• Neutrophil count at least 1,500/mm^3
• Platelet count greater than 70,000/mm^3
• Hemoglobin at least 10.0 g/dL

Hepatic:

• Bilirubin less than 2.0 mg/dL
• SGOT or SGPT less than 3 times upper limit of normal (ULN)*
• Alkaline phosphatase less than 3 times ULN*
• No decompensated liver disease
• No autoimmune hepatitis
• No coagulation disorders NOTE: * Unless due to metastatic disease

Renal:

• Creatinine normal

Cardiovascular:

• No history of severely debilitating cardiovascular disease
• No unstable angina
• No uncontrolled congestive heart failure
• No thrombophlebitis

Pulmonary:

• No history of severely debilitating pulmonary disease
• No chronic obstructive pulmonary disease
• No pulmonary embolism

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study
• No acute infection requiring systemic antibiotics
• No prior hypersensitivity to interferon alfa or any component of the injection
• No diabetes mellitus prone to ketoacidosis
• No severe myelosuppression
• No history of autoimmune disease
• No pre-existing thyroid abnormalities with thyroid function that cannot be maintained in the normal range
• No clinically significant retinal abnormalities
• No other serious medical or psychiatric illness that would preclude study
• No prior malignancy except curatively treated carcinoma in situ of the cervix or skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior systemic chemotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior radiotherapy allowed

Surgery:

• See Disease Characteristics

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Herbert Irving Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Robert N. Taub, MD, PhD

Role: STUDY_CHAIR

Herbert Irving Comprehensive Cancer Center

Locations

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CPMC-IRB-13887

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-2024

Identifier Type: -

Identifier Source: secondary_id

CDR0000069028

Identifier Type: -

Identifier Source: org_study_id