Study of rSIFN-co for Patients with Advanced Solid Tumors
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Scottsdale/Phoenix, Arizona: 15-006013
NCT ID: NCT02464007
Sponsor Protocol Number: STM-04
About this study
The purpose of this study is to evaluate the safety, disease response, and drug /body interactions of rSIFN-co at different dose levels to demonstrate optimal dosage for patients with advanced solid tumors.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Male or female ≥ 18 years of age
- Diagnosis of advanced solid tumors limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor progressing on standard therapy
- Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1
- Prior systemic chemotherapy, immunotherapy (including interferon), or biological therapy, radiation therapy and/or surgery for resection of solid tumor (limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor) are allowed
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Has adequate hepatic function defined as total bilirubin ≤1.5 mg/dL, unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin or ≤ 2 ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 x ULN for known hepatic metastases
- Has adequate renal function defined as serum creatinine or ≤ 1.5 × ULN and creatinine clearance or ≥ 40 ml/min
- Has adequate bone marrow function defined as a hemoglobin > 9 g/dL, absolute neutrophil count (ANC) ≥1.5 ×10⁹/L , and platelet count ≥100,000/mm³
- Subjects who received chemotherapy for melanoma just prior to screening need to have a hemoglobin > 9 g/dL, absolute neutrophil count (ANC) >2 × 10⁹/L, and platelet count ≥100,000/mm³
- Must be willing and able to comply with study visits and procedures
- Has read, understood and signed the informed consent form approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC)
- Women of childbearing potential must not be pregnant (confirmed by a negative serum beta-HCG with a sensitivity of 50 mIU/ml pregnancy test within 7 days of study treatment) or breast-feeding
- A medically acceptable method of birth control must be used such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence during the study and at least one month after the last dose of study drug
- Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be of child bearing potential
- Men who are not surgically or medically sterile must agree to use an acceptable method of contraception
- Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the date of the first dose of study drug through at least one month after the last dose of study drug
- Total abstinence for the same study period is an acceptable alternative
- Chemotherapy, immunotherapy (including interferon), or biological therapy, radiation therapy and/or surgery within 4 weeks prior to first dose of study drug
- Prior mTOR inhibitor therapy within 4 weeks prior to first dose of study drug
- Has a history of autoimmune disorders, including uncontrolled diabetes ("uncontrolled" defined as Hemoglobin A1c ≥ 9% in 28 days prior to study)
- Chronic use of steroid therapy
- Has a history of epilepsy, depression or other psychiatric disorders
- Has a history of an arterial thromboembolic event within the prior six months including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina
- Has uncontrolled human immunodeficiency virus (HIV) (defined as HIV RNA >500 copies/ml and CD4+ count<200/mm³ on antiretroviral therapy) infection, or hepatitis B (defined as ALT > 1 x ULN, and HBV DNA >2000 IU/ml), or hepatitis C (defined as ALT > 1 x ULN, persistent viremia on antiviral therapy) infections
- Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment (patient must be on stable dose for 2 weeks)
- Prior allogeneic bone marrow or organ transplantation
- Has any clinically significant infection, i.e., any acute viral, bacterial, or fungal infection that requires specific treatment (anti-infective treatment has to be completed ≥ 7 days prior to study entry)
- Has any other severe, uncontrolled medical condition, including unstable congestive heart failure (Stage III-IV of the New York Heart Association Functional Classification) or has a known or suspected allergy to the study drug or any study drug component
- Pregnant or breastfeeding - interferon products (e.g., Infergen®) are Pregnancy Category C, (i.e., animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans)
- Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test result obtained during screening
- Pregnancy testing is not required for post-menopausal or surgically sterilized women
- Subject has received other investigational drugs within 14 days prior to first dose of study drug
- Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for enrollment in this study
- Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval > 480 milliseconds)
- Presence of any non-healing wound, fracture, or ulcer within 28 days prior to the first dose of study drug
- Has any condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance
- Has any mental or medical condition that prevents the subject from giving informed consent or participating in the trial
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Ramesh Ramanathan, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office