Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT01883518
Eligibility Criteria:
Inclusion Criteria:
* age of 18 or older
* ECOG performance score 0 or 1
* Histologically proven soft tissue sarcoma
* Unresectable or metastatic soft tissue sarcoma
* Ability to give written informed consent
* Objective measured and measurable tumor lesions
* The failure of standard therapy
* Adequate amount of material for genetic research
* No active or chronic infection with HIV, Hepatitis B or Hepatitis C
* Men/Women of childbearing potential must use adequate contraception
* Hematology, liver function and renal function lab tests within required parameters
Exclusion Criteria:
* Untreated or uncontrolled brain metastases.
* History of other active malignancy within last 2 years, except adequately treated other soft tissue sarcoma.
* Autoimmune disease (vitiligo is not a basis for exclusion).
* Serious uncontrolled medical disorder or active infection that would impede treatment.
* Underlying medical or psychiatric condition that would cause administration vaccine
* Any non-oncology vaccine therapy up to 1 month before or after any dose of vaccine
* Concomitant therapy with IL-2, interferon, other non-study immunotherapy, or cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration; other investigational therapies; chronic use of systemic corticosteroids (however, a low stable dose steroid for mild brain edema or adrenal insufficiency is allowed; topical and inhaled standard dose corticosteroids are allowed).
* Dementia or significantly altered mental status that would prohibit understanding or rendering of informed consent and compliance with protocol requirements.
* Pregnant or breastfeeding women.
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious) illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01883518
Study Brief:
Protocol Section:
NCT01883518