Granulocyte-Macrophage Colony-Stimulating Factor for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Tufts Medical Center, Boston, MA
Carcinoma+4 More
Granulocyte-Macrophage Colony-Stimulating Factor - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

A Study of Sargramostim Plus Pembrolizumab With or Without Pemetrexed in Patients With Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy

See full description

Eligible Conditions

  • Carcinoma
  • Non-Small Cell Carcinoma of Lung, TNM Stage 4
  • Advanced Non-Small Cell Lung Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Granulocyte-Macrophage Colony-Stimulating Factor will improve 2 primary outcomes and 6 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of 24 Months.

24 Months
Progression free survival (PFS)
To evaluate changes in CD4 T at different time points during study treatment
To evaluate changes in CD8 T at different time points during study treatment
To evaluate changes in PD-1+ CD4 at different time points during study treatment
To evaluate changes in PD-1+ CD8 at different time points during study treatment
To evaluate changes in monocytes at different time points during study treatment
To evaluate changes in myeloid derived suppressor cells at different time points during study treatment
24 months
Overall Survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

GM-CSF Plus Maintenance Pembrolizumab +/- Pemetrexed
1 of 1
Experimental Treatment

This trial requires 83 total participants across 1 different treatment group

This trial involves a single treatment. Granulocyte-Macrophage Colony-Stimulating Factor 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 2 and have already been tested with other people.

GM-CSF Plus Maintenance Pembrolizumab +/- PemetrexedAll patients will receive GM-CSF plus maintenance pembrolizumab with or without pemetrexed, following completion of 4 cycles of chemo-immunotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Granulocyte-Macrophage Colony-Stimulating Factor
2017
Completed Phase 1
~20
Carboplatin
FDA approved
Paclitaxel
FDA approved
Pemetrexed
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months for reporting.

Closest Location

Tufts Medical Center - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who are 18 years of age or older are allowed to vote. show original
This person has Stage 4 NSCLC that is not responding to chemotherapy and radiation therapy. show original
criteria was observed in all tumours All tumours had at least one lesion that could be measured using RECIST version 1.1 criteria. show original
for five years She has been able to self-administer the GM-CSF injections on a daily basis for the past five years. show original
For people with this cancer, treatment will involve 4 cycles of a chemoimmunotherapy drug followed by maintenance therapy with a drug called pembrolizumab +/- pemetrexed. show original
PDL-1 of 1%-49%
There is no history of immunotherapy treatment that is known. show original
ECOG PS 0-1
The patient has a life expectancy of at least three months. show original

Patient Q&A Section

Can lung cancer be cured?

"Lung cancer patients often report positive effects from treatment, including a reduction in symptoms. This suggests that the cure rate for patients diagnosed with stage III-IVa disease as defined in recent TNM staging guidelines is a high one." - Anonymous Online Contributor

Unverified Answer

How many people get lung cancer a year in the United States?

"The annual age-adjusted incidence of lung cancer continues to rise, particularly in adults and women. Although the overall yearly death rate may be declining, lung cancer seems to be increasing among men. Current trends suggest that this is due, in part, to the increasing age at the time lung cancers occur, as well as to increased smoking rates as lung cancers have become evident in more mature age groups over the last decade. There is a high incidence of lung cancer in the southern states in the United States, especially among white people." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for lung cancer?

"Patients have profound belief in complementary and alternative therapies to help treat lung cancer. Clinicians can encourage patients to participate in some clinical trials designed to explore complementary and alternative therapies, given the low risk of harm. Clinicians can reassure patients that they will not suffer adverse events from any adverse events associated with participation in this type of research." - Anonymous Online Contributor

Unverified Answer

What are the signs of lung cancer?

"The signs of lung cancer include a persistent cough, hemoptysis a persistent cough, dyspnea, hoarseness, persistent hoarseness and blood in the sputum a persistent cough, dyspnea and hoarseness. These signs and symptoms are more common in women." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lung cancer?

"This review highlights a number of key strategies that can be used to treat patients with lung cancer. This may aid in managing the burden of disease on health services, especially in patients with poorer health literacy." - Anonymous Online Contributor

Unverified Answer

What causes lung cancer?

"Cited research confirms the role of tobacco smoking in the cause of lung cancer. Research also suggests the role of other external causes (occupational factors, environmental hazards), including chemical fumes and air pollution." - Anonymous Online Contributor

Unverified Answer

What is lung cancer?

"The symptoms are similar to pneumonia in patients with [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) answer: Treatment is based on overall staging and performance status. In Stage I-II in NSCLC, surgery is an option for curative care if the patient is medically fit and has no symptoms. Radical thoracic and pulmonary surgery may be performed. In stage III-IV, if the cancer has not been removed by surgery at the time of diagnosis, then the treatment of choice is multimodality therapy. Chemotherapy may be offered if a large disease has been resected by surgery but the disease is still in one of the major lymph nodes." - Anonymous Online Contributor

Unverified Answer

Has granulocyte-macrophage colony-stimulating factor proven to be more effective than a placebo?

"GM-CSF is an effective, well-tolerated, and persistent anticancer therapy with a high probability of inducing durable remissions in patients with relapsed or refractory systemic disease. The low incidence of toxicity is one of its greatest strengths. Further evaluation of this agent requires the randomized comparison with other antimetabolites." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lung cancer?

"Most patients who survived more than two or three years did not have advanced disease at the time of their cancer diagnosed, and many remained asymptomatic with no signs of cancer during their survival period. Since lung cancer is a relatively uncommon cancer – for example, it represents only 4.5% of all cancers in Switzerland, where this study was performed – most patients will die from another cause than from lung cancer. Because most lung cancer patients have a poor prognosis (standardized mortality ratio of 14." - Anonymous Online Contributor

Unverified Answer

Does granulocyte-macrophage colony-stimulating factor improve quality of life for those with lung cancer?

"In this large, prospective, double-blind, placebo-controlled, three-month Phase II study, GM-CSF led to significant improvements in physical and emotional functioning and quality of life for patients with lung cancer. These improvements are similar to improvements seen in the quality of life and physical functioning of patients receiving chemotherapy." - Anonymous Online Contributor

Unverified Answer

What is the latest research for lung cancer?

"The American Cancer Society's Lung Cancer Action Plan is an extensive publication with comprehensive, up-to-date information on the prevention, prediction and treatment of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer). The information is organized into two distinct sections: the clinical information about lung cancer and the facts about prevention and treatment, with a section on lung cancer statistics in alphabetical order across its 15 pages. The facts about prevention and treatment includes information such as lifestyle, nutrition, screening, screening options and treatment options. There is a large amount of data available on how to detect lung cancer and the best treatments to help people overcome the disease. The clinical information section has an overview of symptoms and risks as well as what the most common cancers in the body are." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating lung cancer?

"A new type of a drug, epothilone, has shown potential for treating [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer). With more study and clinical trials, scientists and doctors hope to find the right drug which will treat lung cancer with a minimal chance of harming other parts of the body. Epothilone treats lung cancer by disrupting dividing cancer cells which destroys the tumor and spreads. Epothilone is given and taken by infusion, as the cancer is not near the surface where normal human nerves are. \n\nThere was an earlier discovery, for people with brain metastasis, which was a substance that stopped cancer cells from growing and spreading to other parts of the body." - Anonymous Online Contributor

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