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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026416
First received: November 9, 2001
Last updated: January 3, 2014
Last verified: October 2003
  Purpose

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 Intervention Phase
Sarcoma
Biological: recombinant interferon alfa
Drug: thalidomide
Procedure: adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior systemic chemotherapy allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior radiotherapy allowed

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026416

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
Investigators
Study Chair: Robert N. Taub, MD, PhD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00026416     History of Changes
Other Study ID Numbers: CDR0000069028, CPMC-IRB-13887, NCI-G01-2024
Study First Received: November 9, 2001
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

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:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Interferons
Thalidomide
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 18, 2014