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

NCT00026416 | Unknown Phase 2

• 3 other identifiers: CDR0000069028CPMC-IRB-13887NCI-G01-2024
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

stage III adult soft tissue sarcoma; localized osteosarcoma; metastatic osteosarcoma; stage II adult soft tissue sarcoma; stage IV adult soft tissue sarcoma

Interventions

recombinant interferon alfa BIOLOGICAL

thalidomide DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Herbert Irving Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Sarcoma; Osteosarcoma

Interventions

Interferon-alpha; Thalidomide; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Robert N. Taub, MD, PhD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Last Updated: January 6, 2014

Record last verified: 2003-10

Locations

US (1)