- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00026416
Interferon Alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma
Phase II Study of Low-Dose Interferon Alfa 2B (Schering Plough) Plus Thalidomide (Celgene) for Patients With Resected High-Risk Soft Tissue Sarcoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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New York
-
New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Robert N. Taub, MD, PhD, Herbert Irving Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Interferons
- Interferon-alpha
- Thalidomide
Other Study ID Numbers
- CDR0000069028
- CPMC-IRB-13887
- NCI-G01-2024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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