Interferon Alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma
Recruitment status was Active, not recruiting
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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 |
| Study Start Date: | October 2001 |
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 |
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| United States, New York | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| 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: | February 6, 2009 |
| 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 Interferon-alpha Interferon Alfa-2a Interferons Thalidomide Antiviral Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 22, 2013