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SarcomaPhase 2NCT00026416

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

A Phase 2 study testing recombinant interferon alfa, thalidomide and adjuvant therapy in people with Sarcoma, run by Herbert Irving Comprehensive Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
recombinant interferon alfa, thalidomide and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
1 siteUnited States
Study dates
Oct 2001to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Sarcoma
Being tested
recombinant interferon alfa, thalidomide, adjuvant therapy
Keywords
stage III adult soft tissue sarcoma, localized osteosarcoma, metastatic osteosarcoma, stage II adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
Medical subject headings
Sarcoma, Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interferon alfaBiological

  • thalidomideDrug

  • adjuvant therapyProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00026416
Sponsor's protocol ID
CDR0000069028
Other IDs
CPMC-IRB-13887, NCI-G01-2024
Status last verified
Oct 2003
First submitted
9 Nov 2001
Last updated
6 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing recombinant interferon alfa, thalidomide and adjuvant therapy in people with Sarcoma, run by Herbert Irving Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.

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