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Phase II Study of Low-Dose Interferon Alfa 2B (Schering Plough) Plus Thalidomide (Celgene) for Patients With Resected High-Risk Soft Tissue Sarcoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Sarcoma

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Trial Information

Phase II Study of Low-Dose Interferon Alfa 2B (Schering Plough) Plus Thalidomide (Celgene) for Patients With Resected High-Risk Soft Tissue Sarcoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert N. Taub, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069028

NCT ID:

NCT00026416

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Sarcoma
  • stage III adult soft tissue sarcoma
  • localized osteosarcoma
  • metastatic osteosarcoma
  • stage II adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma

Name

Location

Herbert Irving Comprehensive Cancer CenterNew York, New York  10032