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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00026416
Recruitment Status : Unknown
Verified October 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Sarcoma Biological: recombinant interferon alfa Drug: thalidomide Procedure: adjuvant therapy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Study of Low-Dose Interferon Alfa 2B (Schering Plough) Plus Thalidomide (Celgene) for Patients With Resected High-Risk Soft Tissue Sarcoma
Study Start Date : October 2001

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • More than 2 months


  • 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


  • 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


  • Creatinine normal


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


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


  • 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


Biologic therapy:

  • Not specified


  • Prior systemic chemotherapy allowed

Endocrine therapy:

  • Not specified


  • Prior radiotherapy allowed


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00026416

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United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
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Study Chair: Robert N. Taub, MD, PhD Herbert Irving Comprehensive Cancer Center
Layout table for additonal information Identifier: NCT00026416    
Other Study ID Numbers: CDR0000069028
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: October 2003
Keywords provided by National Cancer Institute (NCI):
stage III adult soft tissue sarcoma
localized osteosarcoma
metastatic osteosarcoma
stage II adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors