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

Herbert Irving Comprehensive Cancer Center

Status and phase

Unknown

Phase 2

Conditions

Sarcoma

Treatments

Biological: recombinant interferon alfa

Procedure: adjuvant therapy

Drug: thalidomide

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00026416

CDR0000069028

CPMC-IRB-13887

NCI-G01-2024

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary or metastatic soft tissue sarcoma or bone sarcoma at high risk of recurrence
- Grade III-IV tumor greater than 8 cm
- Grade III-IV primary tumor greater than 5 cm with positive surgical margins
- Grade III-IV primary tumor greater than 5 cm with distant metastases resected within 1 year of primary surgery
No more than 8 weeks since prior surgical resection of primary or metastatic disease
Ineligible for other high priority national or institutional study

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