CLINICAL TRIAL

galinpepimut-S for Small Cell Lung Carcinoma

Locally Advanced
Metastatic
Newly Diagnosed
Recurrent
Refractory
Waitlist Available · 18+ · All Sexes · Cincinnati, OH

This study is evaluating whether a combination of two drugs may help treat patients with advanced cancers.

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About the trial for Small Cell Lung Carcinoma

Eligible Conditions
Leukemia, Myeloid, Acute · Small-cell Lung Cancer · Triple-negative Breast Cancer · Leukemia, Myeloid · Colorectal Carcinoma (CRC) · Ovarian Cancer · Triple Negative Breast Neoplasms · Acute Myeloid Leukemia (AML) · 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.

Experimental Group 1
Pembrolizumab
DRUG
+
galinpepimut-S
BIOLOGICAL
Experimental Group 2
Pembrolizumab
DRUG
+
galinpepimut-S
BIOLOGICAL
Experimental Group 3
Pembrolizumab
DRUG
+
galinpepimut-S
BIOLOGICAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People with advanced or metastatic solid tumors that have continued to progress after treatment with available therapies, or who are intolerant to treatment, or refuse standard treatment, may be eligible for participation in this study show original
, was associated with a significantly improved OS Having cytoreductive therapy with hydroxyurea or leukapheresis at the time of initial diagnosis, and then transitioning immediately to HMA therapy, was associated with a significantly improved OS. show original
who met all inclusion criteria Patients who are male or female and are at least 18 years old on the day they sign the informed consent form are eligible for the study show original
Patients in both the solid tumor and AML arms of the study will have their initial primary tumor or recent biopsy of metastatic disease tested for WT1 expression via IHC show original
Some patients may have only received two or three lines of therapy for metastatic colorectal cancer, one or two lines for ovarian cancer, one line for small cell lung cancer, and one line for triple negative breast cancer show original
In order to be eligible for the solid tumor arms of the study, patients must have measurable disease based on RECIST v1.1 as determined by the local study team. show original
I can understand and agree to the terms of the study, and am able to sign the informed consent form. show original
Status The person has been a frontline patient with HMAs since they were first diagnosed with AML. show original
History of induction early failure after initial therapy with up to 2 cycles of standard chemotherapy ("7+3" or similar regimen), with subsequent immediate seamless transitioning to HMA therapy as long as patients have achieved PR as their best observable response after 4 cycles of HMA therapy; HMA therapy continues throughout the trial period.
Resolution of toxicity effect(s) from most recent prior chemotherapy to Grade 1 or less (except alopecia). If the patient received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
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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: First 9 weeks up to 32 months
Screening: ~3 weeks
Treatment: Varies
Reporting: First 9 weeks up to 32 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: First 9 weeks up to 32 months.
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 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.

Progression-free survival (PFS) - Exploratory endpoint - for solid tumor arms
UP TO 32 MONTHS
From time of registration to the time of documented disease progression per RECIST 1.1 or subject death (for solid tumors).
UP TO 32 MONTHS
Overall survival (OS) - Exploratory endpoint - for all tumor types
UP TO 32 MONTHS
From time of registration to the time of subject death.
UP TO 32 MONTHS
Progression-free survival (PFS) - Exploratory endpoint - for AML arm only
UP TO 32 MONTHS
From time of registration to the time of documented morphological leukemic relapse or subject death. PFS is equivalent to leukemia-free survival (LFS) (for AML arm only).
UP TO 32 MONTHS
Immune Response (IR) to WT1 peptides within the vaccine mixture - Galinpepimut-S Pharmacodynamics - Exploratory endpoint - for all tumor types
BASELINE (PRE-TREATMENT) AND FIRST 9 WEEKS UP TO 32 MONTHS (POST-TREATMENT)
WT1 (epitope/antigen)-specific T-cell (CD8 and CD4) immune response dynamics in peripheral blood (PB) and select general immunodynamics assessments (in PB and tissue samples, as applicable; e.g., immunophenotyping of lymphocyte & NK cell subpopulations in PB via flow cytometry).
BASELINE (PRE-TREATMENT) AND FIRST 9 WEEKS UP TO 32 MONTHS (POST-TREATMENT)
PD Ligand 1 (PDL-1) expression in bone marrow biopsy samples - Pembrolizumab Pharmacodynamics - Exploratory Exploratory endpoint - for AML arm only
BASELINE (PRE-TREATMENT) AND FIRST 9 WEEKS UP TO 32 MONTHS (POST-TREATMENT)
Programmed death-ligand 1 (PD-L1), also known as cluster of differentiation 274 (CD274) or B7 homolog 1 (B7-H1), expression in bone marrow biopsy samples by a validated assay (for AML arm only).
BASELINE (PRE-TREATMENT) AND FIRST 9 WEEKS UP TO 32 MONTHS (POST-TREATMENT)
PD Ligand 1 (PDL-1) expression in malignant tissue biopsy samples - Pembrolizumab Pharmacodynamics - Exploratory Exploratory endpoint - for solid tumor arms
BASELINE (PRE-TREATMENT) AND FIRST 9 WEEKS UP TO 32 MONTHS (POST-TREATMENT)
Programmed death-ligand 1 (PD-L1), also known as cluster of differentiation 274 (CD274) or B7 homolog 1 (B7-H1), expression in malignant tissue biopsy samples by a validated assay (for solid tumors only).
BASELINE (PRE-TREATMENT) AND FIRST 9 WEEKS UP TO 32 MONTHS (POST-TREATMENT)
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Patient Q & A Section

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

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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