CLINICAL TRIAL

rSIFN-co for Neuroendocrine Tumors

Locally Advanced
Metastatic
Waitlist Available · 18+ · All Sexes · Chicago, IL

This study is evaluating whether a dose of rSIFN-co can be determined that is safe and effective.

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About the trial for Neuroendocrine Tumors

Eligible Conditions
Neuroendocrine Tumors · Malignancies Including Melanoma, Kidney, Lung, Colorectal, Prostate, Neuroendocrine Tumor

Treatment Groups

This trial involves 2 different treatments. RSIFN-co is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
rSIFN-co
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Recombinant Super-Compound Interferon
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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.
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 subjects with known hepatic metastases.
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. For subjects who received chemotherapy for melanoma just prior to screening for the study subject needs 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 (ICF) approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
Male or female ≥ 18 years of age
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 renal function defined as serum creatinine or ≤ 1.5 × ULN and creatinine clearance or ≥ 40 ml/min.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 28-days
Screening: ~3 weeks
Treatment: Varies
Reporting: 28-days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 28-days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether rSIFN-co will improve 1 primary outcome in patients with Neuroendocrine Tumors. Measurement will happen over the course of 28-days.

Maximum Tolerated Dose
28-DAYS
28-DAYS

Patient Q & A Section

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

Have there been other clinical trials involving rsifn-co?

There have only been few phase II and phase III clinical trials using FSHR as a drug target. However, since the advent of rifn-co, there have been some positive results for it as a monotherapy. In our opinion, it is now more likely that FSHR and rifn-co could be combined with the use of FSHR agonists in a new treatment strategy for patients with endocrine tumors.

Anonymous Patient Answer

What causes neuroendocrine tumors?

Many different genetic, environmental and epigenetic changes occur simultaneously in many of NSECs during their tumorigenesis. The underlying cellular determinants for disease formation in a specific tumor remain unresolved, making the underlying mechanisms important for establishing the optimal approaches to targeted treatments.

Anonymous Patient Answer

How many people get neuroendocrine tumors a year in the United States?

About 11 million people at some point in a year have at least one primary neuroendocrine tumor. These people are more likely to experience aggressive tumor behavior.

Anonymous Patient Answer

What are the signs of neuroendocrine tumors?

Most NETs are characterized by diarrhea, diarrhea with blood, excessive flushing or pallor, and/or weight loss. In contrast, some patients with NET have signs such as osteomalacia, acromegaly, or hypercalcemia. In patients with NET, bone lesions such as osteomas, fibrous dysplasia, and osteolytic areas should be sought.

Anonymous Patient Answer

What is neuroendocrine tumors?

Neuroendocrine tumors are neoplasms that arise outside of the usual sites of cellular differentiation and include tumors of all kinds of hormones and peptides, including hormones, antigens, and growth factors. They arise from cells of different origins in the body and are typically classified according to their cell of origin. The diagnosis of neuroendocrine tumors requires a thorough anatomical, medical, and medical-pathological investigation to exclude other possible tumor diagnoses. The initial management is often surgical. If there is limited or no evidence of a mass or other anatomic abnormality, it should be followed closely for the development of metastasis.

Anonymous Patient Answer

Can neuroendocrine tumors be cured?

NE tumors are highly malignant, but with appropriate treatment in selected patients, they have a potential cure in many cases. For example, low-grade, limited-stage, well-differentiated (well-differentiated, limited-stage, well-differentiated, and low Ki67 proliferative index), low-grade, well-differentiated, limited-stage, pancreatic-type, and low proliferative index neuroendocrine tumors with either local or distant relapse were cured or had a long survival. NE tumors without distant metastasis were cured or had a long survival when limited to local relapse.

Anonymous Patient Answer

What are common treatments for neuroendocrine tumors?

Most patients with NEN respond well to treatment with either surgery, radiation therapy, targeted therapy, or chemoimmunotherapy. However, patients with unresectable or progressive disease at presentation are almost always treated with palliative intent only.

Anonymous Patient Answer

What is the survival rate for neuroendocrine tumors?

Neuroendocrine tumors, like most other types of tumors, have a 10-year overall survival rate of 25-30% depending on the type of tumor. The strongest prognostic indicator of outcome is performance status (function of the patient and how they think they should act) at time of neuroendocrine tumor diagnosis.

Anonymous Patient Answer

Have there been any new discoveries for treating neuroendocrine tumors?

There are no new exciting treatments for PNETs. In patients with high-grade PNET, chemotherapy with a biologic agent can be considered. In low-grade PNETs, if the disease is very low in volume and high in the organs, a biologic agent may be useful. For patients with high-grade PNETs and metastatic disease, chemotherapy can still be considered. If there are no symptoms, a biologic agent is not needed. Patients with low-grade tumors should begin chemotherapy with a biologic agent after other therapies have failed.

Anonymous Patient Answer

What are the chances of developing neuroendocrine tumors?

Patients with MEN I have a 50% risk of developing at least a NET, while patients with an MEN IIA are 20% to 30% at risk. A more aggressive surveillance is required for patients who have MEN II. The presence of multiple NETs, but not the location of the first tumor in the body, predicts the risk of developing additional NETs.

Anonymous Patient Answer

Does rsifn-co improve quality of life for those with neuroendocrine tumors?

Recent findings did not demonstrate that administering an RSF-co improves patients' QOL. However, our study supports the importance of QOL assessments and supports its inclusion in future clinical trials.

Anonymous Patient Answer

How serious can neuroendocrine tumors be?

Rare, but potentially life-threatening, neuroendocrine tumors can be serious. Patients with gastrointestinal stromal tumors present with nonbiliary symptoms. Patients with somatostatin analog therapy present with progressive hepatic failure, renal tubular dysfunction, and progressive gastrointestinal dysfunction. Patients with malignant tumors may present with cardiopulmonary symptoms or, more commonly, pulmonary symptoms. Patients with medullary thyroid carcinoma commonly present with dysphagia. These tumors, like neuroendocrine tumors, should be considered in the differential diagnosis of patients with nonbiliary symptoms.

Anonymous Patient Answer
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