Topic 01
Investigational targeted research
What the published research describes about investigational, research-stage approaches for solid tumors that overexpress voltage-gated sodium channels. Investigational and not FDA approved.
Independent educational resource
Understanding the science of advanced cancer.
Plain-language education for people who want to understand advanced solid tumor cancer biology and the investigational research being studied. This is general information, not medical advice, and no treatment is offered here. For the full research record, see FixCancer.org.
- Cancer Biology Explained
- Investigational Research
- Educational Only
- Not Medical Advice
7
Peer-reviewed TOL publications
0
FDA-approved TOL products
0
Registered human trials on ClinicalTrials.gov
Public Education Layer, Evidence at a Glance
What the research actually shows.
Targeted Osmotic Lysis is investigational. Most published evidence is preclinical or veterinary, and the human evidence is limited to a single emergency-use case report. There are no published randomized trials, no human trials registered on ClinicalTrials.gov, and no FDA approval. Safety and effectiveness in humans are not established.
Verifiable references on PubMed, PMID 35453588, PMID 36230549, PMID 29643996, PMID 32486340, PMID 35967596, PMID 34201380, and PMID 39681070.
Three topics to understand
Understanding the landscape of advanced cancer research.
These are educational topics, not a menu of services. This site does not offer, recommend, or arrange treatment. Discuss any option with your licensed oncologist.
Topic 02
Second opinions, in general terms
How second opinions and re-staging work through academic medical centers and NCI-designated comprehensive cancer centers. General education only, arranged through your own care team, not through this site.
Find trusted sourcesTopic 03
How clinical trials work
How to understand clinical trials, early-phase research, and the FDA frameworks that govern investigational therapies. Trial searches are run through ClinicalTrials.gov and your care team.
How trials workEducation guide
A practical guide to understanding advanced cancer.
How to learn about advanced cancer and the research, and how to take questions to your own care team. Educational only, not medical advice.
What advanced cancer means
Advanced cancer covers stage 3 and stage 4 disease. Stage 3 disease has spread to regional lymph nodes or nearby tissue. Stage 4 disease has metastasized to distant organs. The treatment plan changes when standard first-line and second-line therapies stop producing durable response.
Most patients reach this point after a sequence of surgery, chemotherapy, radiation, and immunotherapy. The next conversation should center on three questions. What therapies remain that have not been tried. What clinical trials match the tumor profile. What targeted approaches are available outside the standard pathway.
The right question is not "what is next on the standard ladder." The right question is "what targeted option matches this specific tumor."
Targeted therapy in plain language
Targeted cancer therapy attacks specific molecular features of cancer cells. The features differ by tumor type. Some tumors over-express a surface receptor. Others over-express an ion channel. Targeted therapy uses that difference to selectively damage cancer cells while sparing normal tissue.
In the published research rationale, the aim is to concentrate activity on the tumor and reduce the side-effect burden associated with traditional cytotoxic chemotherapy. This describes the research goal. It is not a statement of proven benefit, and investigational approaches have not established safety or effectiveness in humans.
Solid tumors studied in targeted-therapy research
- Breast cancer including triple-negative subtypes
- Prostate cancer including castration-resistant disease
- Colorectal cancer including KRAS-mutant subtypes
- Lung cancer including non-small cell lung cancer
- Ovarian cancer
- Pancreatic cancer
- Melanoma and other skin cancers
- Gastric and esophageal cancers
Hematologic cancers and bone marrow primary cancers fall outside the scope of solid tumor targeted therapy. Patients in those categories should consult a hematologist-oncologist directly.
How investigational research is discussed with an oncologist
People sometimes ask their oncologist about investigational research in situations like these. This is educational context, not eligibility criteria, and this site does not screen anyone.
- The cancer has progressed on two or more standard therapy lines.
- The patient cannot tolerate further cytotoxic therapy on clinical grounds.
- The patient wants to understand options for a future line of therapy.
Any such discussion belongs with a licensed oncologist, who reviews pathology, imaging, prior treatment, current performance status, and lab values. This educational site does not assess eligibility or schedule anything.
How investigational therapies are regulated
In the United States, the FDA oversees how investigational therapies are studied. Most access happens through enrollment in a registered clinical trial. In defined circumstances, expanded access and the federal Right to Try framework let a treating physician request an investigational therapy for a patient with a serious or life-threatening condition and no comparable approved option. This is general education. This site does not arrange access, screen patients, or maintain a treatment directory.
Questions to ask your oncologist
- What molecular profiling has been done on the tumor?
- What targetable mutations or expression patterns are present?
- What clinical trials match the molecular profile?
- What expanded-access programs exist for this tumor type?
- How does the proposed next-line therapy compare with investigational research?
How to learn more
Start with the published research and the primary-source citations on FixCancer.org. Verify each cited PubMed identifier independently. Then discuss any option with your licensed oncologist. This educational site does not run an intake, assess eligibility, or arrange care, and it does not quote prices.
Cancer, explained
What cancer is.
Plain-language basics drawn from the National Cancer Institute. This is general health information, not medical advice.
Cancer is a disease in which some of the body's cells grow uncontrollably and spread to other parts of the body. Normally, cells grow and divide to form new cells as the body needs them, and old or damaged cells die. Sometimes that orderly process breaks down. Abnormal cells grow when they should not, and they can form lumps of tissue called tumors.
Tumors can be cancerous or benign. Cancerous tumors invade nearby tissue and can travel to distant parts of the body to form new tumors. Many cancers form solid tumors. Cancers of the blood, such as leukemias, generally do not. There are more than 100 types of cancer, usually named for the organ or tissue where they form. Source: National Cancer Institute, What Is Cancer.
How cancer cells differ from normal cells
Cancer cells grow without the signals that normal cells wait for. They ignore signals that tell cells to stop dividing or to die. They can invade nearby areas, spread to other parts of the body, and hide from the immune system. Researchers study these differences to design therapies that target the abnormal features of cancer cells.
Diagnosis and staging
Understanding cancer stages.
Stage describes how much cancer is in the body and how far it has spread. Knowing the stage helps a care team understand how serious a cancer is and plan treatment.
The TNM system
Most hospitals use the TNM system. T refers to the size and extent of the main tumor. N refers to the number of nearby lymph nodes that contain cancer. M refers to whether the cancer has metastasized, meaning it has spread from the primary tumor to other parts of the body.
Stage groups
- Stage 0. Abnormal cells are present but have not spread to nearby tissue. Also called carcinoma in situ.
- Stage 1, 2, and 3. Cancer is present. A higher number means a larger tumor that has grown more deeply into nearby tissue.
- Stage 4. The cancer has spread to distant parts of the body.
A cancer registry may also describe cancer as in situ, localized, regional, or distant. A cancer is referred to by the stage it was given at diagnosis, even if it later changes. Source: National Cancer Institute, Cancer Staging.
When cancer spreads
Advanced and metastatic cancer.
Advanced cancer is a general term. It often refers to cancer that has spread and is unlikely to be cured, though treatment may still control it.
A cancer that has spread from where it first formed to another place in the body is called metastatic cancer. Metastatic cancer has the same name and the same type of cancer cells as the original cancer. Breast cancer that forms a tumor in the lung, for example, is metastatic breast cancer, not lung cancer.
For some people with metastatic cancer, treatment may help them live longer. For others, the goal of treatment is to control the cancer's growth or to relieve symptoms. Decisions about advanced cancer belong with a treating oncologist who knows the full medical picture, including pathology, imaging, and prior treatment. Source: National Cancer Institute, What Is Cancer and Metastatic Cancer.
Treatment
Types of cancer treatment.
Most people with cancer receive a combination of treatments. The types depend on the kind of cancer and how advanced it is. The list below summarizes the categories the National Cancer Institute describes.
- Surgery. A procedure to remove cancer from the body.
- Chemotherapy. Drugs that kill or slow the growth of cancer and other fast-growing cells.
- Radiation therapy. High doses of radiation to kill cancer cells and shrink tumors.
- Immunotherapy. Treatment that helps the immune system fight cancer.
- Targeted therapy. Treatment that acts on specific changes in cancer cells that help them grow, divide, and spread.
- Hormone therapy. Treatment that slows or stops the growth of cancers that use hormones to grow, such as some breast and prostate cancers.
- Stem cell transplant. A procedure that restores blood-forming stem cells after high doses of chemotherapy or radiation.
- Hyperthermia and photodynamic therapy. Approaches that use heat, or a light-activated drug, to damage cancer cells.
Biomarker testing can help a patient and doctor choose among these options. Source: National Cancer Institute, Types of Cancer Treatment.
Research participation
How clinical trials work.
Clinical trials test new treatments in a series of steps called phases. Each trial has eligibility criteria that decide who can join.
The four phases
- Phase 1. A small group, often 15 to 30 people, helps researchers learn whether a new treatment is safe, what its side effects are, and a safe dose.
- Phase 2. A larger group, often 50 to 100 people, helps show whether the treatment works against the cancer while safety study continues.
- Phase 3. The treatment is compared with current standard therapy in larger numbers of people, often using random assignment to reduce bias.
- Phase 4. After FDA approval, long-term safety and effectiveness are followed in large, diverse populations.
Results from phase 1 through 3 trials inform decisions by agencies such as the FDA about approving treatments. You can search for cancer clinical trials through ClinicalTrials.gov and the National Cancer Institute, and your care team can help match a trial to a tumor's profile. Source: National Cancer Institute, How Do Clinical Trials Work.
Awareness
Investigational research, explained.
An awareness summary of one area of published research. It is investigational, not an approved or proven treatment, and nothing here is medical advice.
Investigational means a therapy is still being studied and is not approved by the FDA. Investigational approaches have not established safety or effectiveness in humans through controlled trials.
One published line of research studies solid tumor cells that overexpress voltage-gated sodium channels. This approach, named Targeted Osmotic Lysis, appears in peer-reviewed laboratory studies, veterinary studies, and a single human emergency-use case report. There are no published randomized trials, no human trials registered on ClinicalTrials.gov, and no FDA approval. Safety and effectiveness in humans are not established. No claim of cure, benefit, or efficacy is made here.
The references can be verified on PubMed: PMID 35453588, 36230549, 29643996, 32486340, 35967596, 34201380, and 39681070. The full research record is documented at FixCancer.org. Discuss any option with a licensed oncologist.
Trusted sources
Where to find reliable information.
Start with public, authoritative sources. These organizations publish accurate, current cancer information for patients and families.
National Cancer Institute
Plain-language information on every cancer type, diagnosis, staging, and treatment. Contact Center 1-800-4-CANCER.
cancer.govClinicalTrials.gov
A federal registry of clinical studies, including who is eligible and where trials take place.
clinicaltrials.govMedlinePlus
Health information for patients from the National Library of Medicine.
medlineplus.govNCI-designated cancer centers
Academic centers that offer second opinions, molecular profiling, and access to trials.
Find a centerSources
References for this page.
- National Cancer Institute. What Is Cancer. Updated October 11, 2021. cancer.gov/about-cancer/understanding/what-is-cancer
- National Cancer Institute. Cancer Staging. Reviewed October 14, 2022. cancer.gov/about-cancer/diagnosis-staging/staging
- National Cancer Institute. Types of Cancer Treatment. cancer.gov/about-cancer/treatment/types
- National Cancer Institute. How Do Clinical Trials Work. Updated November 8, 2024. cancer.gov/research/participate/clinical-trials/how-trials-work
- Peer-reviewed research on Targeted Osmotic Lysis, verifiable on PubMed: PMID 35453588, 36230549, 29643996, 32486340, 35967596, 34201380, 39681070.
National Cancer Institute content is a work of the U.S. government and is cited and linked per NCI reuse guidance. No NCI text, images, or assets are reproduced on this page.
Frequently asked questions
Common educational questions.
General educational answers. This site does not offer, recommend, or arrange treatment, and nothing here is medical advice.
What is targeted cancer therapy?
Targeted cancer therapy is a research concept that focuses on specific molecular features of cancer cells rather than dividing cells in general. The research goal is to reduce damage to healthy tissue compared with traditional chemotherapy and radiation. This is a general description, not a claim of proven benefit.
What does investigational mean?
Investigational means a therapy is still being studied and is not FDA approved. Investigational approaches have not established safety or effectiveness in humans through controlled trials. This site is educational and does not assess eligibility or arrange anything.
What cancer biology does the TOL research study?
The published research studies solid tumor cells that overexpress voltage-gated sodium channels, in laboratory and veterinary models of breast, prostate, colorectal, lung, ovarian, pancreatic, gastric, and melanoma carcinomas. The literature describes hematologic and bone marrow cancers as outside that rationale. This is research context, not a statement that TOL treats any cancer in humans.
How do I get a second opinion on a cancer diagnosis?
Second opinions are available through academic medical centers, NCI-designated comprehensive cancer centers, and patient navigation services. This educational site does not provide second opinions. Ask your care team how to request your pathology slides, imaging, and treatment summary.
Does this site quote a cost or arrange treatment?
No. This educational site does not offer treatment, quote prices, or arrange care. The cost of any medical care is set by licensed providers under applicable law, not by this site.
What is the state of the evidence for TOL?
Most published evidence is preclinical or veterinary, with a single human emergency-use case report. There are no published randomized trials, no human trials registered on ClinicalTrials.gov, and no FDA approval. Safety and effectiveness in humans are not established.
What is the difference between FixCancers.com and FixCancer.org?
FixCancers.com is an educational and awareness companion. FixCancer.org is the primary research home and documents Targeted Osmotic Lysis in detail. Both are educational and neither offers or arranges treatment.
Learn more
Educational information, not a clinic.
FixCancers.com does not offer treatment, take appointments, assess eligibility, or quote prices. For decisions about your care, talk with a licensed oncologist. For trusted background reading, start with the National Cancer Institute. For the full research record on the science described here, see FixCancer.org.