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.
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
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.
- First posted27 Jan 2003 (estimated)
- Study startOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Herbert Irving Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Robert N. Taub, MD, PhD, Study chair, Herbert Irving Comprehensive Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00026416
- Acronym / sponsor ID
- CDR0000069028
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Herbert Irving Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| thalidomide | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert N. Taub, MD, PhD study chair
Herbert Irving Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
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.