galinpepimut-S for Small Cell Lung Carcinoma
This study is evaluating whether a combination of two drugs may help treat patients with advanced cancers.
See full descriptionAbout the trial for Small Cell Lung Carcinoma
Treatment Groups
This trial involves 5 different treatments. Galinpepimut-S is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Small Cell Lung Carcinoma or one of the other 8 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether galinpepimut-S will improve 3 primary outcomes, 5 secondary outcomes, and 7 other outcomes in patients with Small Cell Lung Carcinoma. Measurement will happen over the course of Up to 32 months.
Patient Q & A Section
What are common treatments for small cell lung carcinoma?
There are several chemotherapeutic regimens for SCLC, including carboplatin/paclitaxel, docetaxel, and cyclophosphamide/nitracoxib; the platinum-based agents are the current standard of care. In addition, many newer treatments are now investigated. Some of the new agents include irinotecan, gemcitabine and pemetrexed.
What are the signs of small cell lung carcinoma?
These include loss or gain of weight, a fast heart rate (tachycardia), shortness of breath, low blood pressure (orthostatic hypotension), unexplained haemoptysis (bloody sputum), and an undescended testicle in males.
What is small cell lung carcinoma?
SCLC is a cancer that forms within the lung tissues and causes uncontrolled cell growth. It is the most common form of lung cancer worldwide. On the cellular level, it is a cancer of cancer stem cells that have the ability to develop into tumorigenesis. SCLC is named for its similarity to small cell carcinoma of other organ families. SCLC is characterized by many tumor cells that are similar in morphology and physiology. These tumor cells form a solid tumor that is composed of epithelial cells that exhibit squamous or cuboidal features.
What causes small cell lung carcinoma?
Although the cause of SCLC is unknown, smoking appears to be an important risk factor, and the risk is lower in women, in good socioeconomic circumstances. The risk of developing malignant mesothelioma is low but not zero. The risk for stomach cancer may be related to the risk of gastrointestinal cancer.
How many people get small cell lung carcinoma a year in the United States?
Small cell lung carcinoma is the second most common form of lung cancer in the United States occurring in around 20,700 people yearly. This equates to 2.6% of all lung cancers in the United States. Smoking is the strongest risk factor of small cell lung carcinoma.
Can small cell lung carcinoma be cured?
The prognosis of patients with small cell lung carcinoma is not always dismal. A complete resection of the primary tumour is the most important factor associated with prolonged survival. The role in treatment of the metastatic disease remains to be determined.
How does galinpepimut-s work?
In this article, we describe our method for preparing galinpepimut-s and its role as a cytotoxic immunotherapy in the treatment of patients with advanced, incurable stage III or IV non-small cell lung cancer.
What is the latest research for small cell lung carcinoma?
With advances in treatment, survival times for patients with SCLC have noticeably increased over time since diagnosis, most notably as a result of better therapy, earlier detection, and better treatment selection. The National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Program is one of the few sources nationwide for up-to-the-minute epidemiological and survival data. The SEER Database provides the best source of data available for research on SCLC. SEER has provided many new information elements on [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer), such as information on smoking prevalence, disease duration, incidence, and survival data from the time of diagnosis. The SEER database is also the most precise source of statistical information for any cancer in the country.
What is galinpepimut-s?
Given that a Phase I Study was recently completed, a Phase 3 trial is now in preparation (Clinicaltrials.gov identifier: NCT01133922), to evaluate galinpepimut as an immunotherapeutic in combination with paclitaxel in patients with metastatic small-cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) (SCLC). In 2017, the authors were awarded Fast Track status by the FDA for their breakthrough cancer drug discovery work. The combination of paclitaxel with galinpepimut is believed to be potentially effective as a standard of care for SCLC treatment in certain circumstances, which could be life saving for many patients.
How serious can small cell lung carcinoma be?
SCC is a highly aggressive disease associated with a poor prognosis. It is therefore important to discuss the potential benefits of treatment with palliative care, aggressive chemotherapy (e.g., Carboplatin and Etoposide) prior to curative treatment.
Does small cell lung carcinoma run in families?
In a recent study, findings provide no evidence for the inheritance of SCLC in families and in the sporadic cases only a weak statistical trend towards an excess of siblings with SCLC, although in all five familial cases both members of the family had SCLC.
What is the primary cause of small cell lung carcinoma?
Lymphocytic alveolitis has been postulated for many years to be associated with lung tumors occurring in AIDS and possibly in other immunocompromised states, and this is one mechanism of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) in AIDS. We showed that in the absence of evidence of lymphocytic alveolitis small cell cancer had an almost equal probability of being associated with other lung diseases, including tuberculosis, nontuberculous mycobacterial infections, and opportunistic diseases such as cytomegalovirus or Pneumocystis carinii pneumonia. The findings of this study refute the assertion of LAP that small cell lung cancer in AIDS should not be considered as pure small cell carcinoma.