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Interferon

Interferon Alfa + Thalidomide for Sarcoma

Phase 2

Waitlist Available

Research Sponsored by Herbert Irving Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age 18 and over

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well combining interferon alfa and thalidomide works in treating patients with soft tissue sarcoma or bone sarcoma.

Who is the study for?

This trial is for adults who've had surgery for high-risk soft tissue or bone sarcoma, with large tumors (over 5 cm) or those that have spread. Participants should not be in other major studies, must use effective contraception if fertile, and can't join if they have severe heart issues, certain pre-existing conditions like uncontrolled diabetes or autoimmune diseases, are pregnant/nursing, or have a history of serious illnesses that could affect participation.Check my eligibility

What is being tested?

The study tests combining interferon alfa (a substance that can inhibit cancer growth) with thalidomide (which may cut off blood supply to tumors), aiming to see if this duo is more effective in killing tumor cells post-surgery in patients with soft tissue or bone sarcoma.See study design

What are the potential side effects?

Potential side effects include fatigue, flu-like symptoms from interferon alfa; while thalidomide may cause drowsiness, rash, nerve damage leading to numbness/tingling/pain in the hands/feet. Both drugs carry risks of birth defects and should be used cautiously by those who are pregnant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My kidney function is normal.

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My large, high-grade tumor was removed along with its distant spread within a year of the first surgery.

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My sarcoma is confirmed and at high risk of coming back.

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My tumor is larger than 5 cm, high grade, and not fully removed by surgery.

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I don't have severe heart disease or uncontrolled heart conditions.

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My tumor is larger than 8 cm and is classified as high grade.

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I don't have severe lung disease, COPD, or a history of blood clots in my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Herbert Irving Comprehensive Cancer CenterLead Sponsor

33 Previous Clinical Trials

929 Total Patients Enrolled

4 Trials studying Sarcoma

52 Patients Enrolled for Sarcoma

National Cancer Institute (NCI)NIH

13,646 Previous Clinical Trials

40,931,027 Total Patients Enrolled

453 Trials studying Sarcoma

230,099 Patients Enrolled for Sarcoma

Robert N. Taub, MD, PhDStudy ChairHerbert Irving Comprehensive Cancer Center

6 Previous Clinical Trials

109 Total Patients Enrolled

4 Trials studying Sarcoma

52 Patients Enrolled for Sarcoma

Media Library

Interferon Alfa (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT00026416 — Phase 2

Sarcoma Clinical Trial 2023: Interferon Alfa Highlights & Side Effects. Trial Name: NCT00026416 — Phase 2

Interferon Alfa (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00026416 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this medical experiment open to the public?

"This clinical trial has not been actively recruiting patients since the last update on January 3rd 2014, according to the data posted by clinicaltrials.gov. Although this research is no longer enrolling subjects at present, there are 443 other studies that are still searching for participants."

Answered by AI

Has this medical therapy obtained the necessary sanction from FDA authorities?

"With clinical data supporting its safety, this intervention was scored a 2. Note that efficacy has yet to be established due to the experimental nature of Phase 2 trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2001. "Interferon Alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00026416.

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