search
Back to results

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

Primary Purpose

Sarcoma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa
thalidomide
adjuvant therapy
Sponsored by
Herbert Irving Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring stage III adult soft tissue sarcoma, localized osteosarcoma, metastatic osteosarcoma, stage II adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 9, 2001
Last Updated
January 3, 2014
Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00026416
Brief Title
Interferon Alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma
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 Type
Interventional

2. Study Status

Record Verification Date
October 2003
Overall Recruitment Status
Unknown status
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
stage III adult soft tissue sarcoma, localized osteosarcoma, metastatic osteosarcoma, stage II adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
thalidomide
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert N. Taub, MD, PhD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs