Clinical trials: sargramostim
Drug Kinetics, Drug Effects on Physiology
Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Sargramostim Administered Subcutaneously, Intravenously, or by Inhalation
This single center, single ascending dose (SAD) and repeat dose study in healthy adults comprises 2 parts. Part 1 will consist of 6 SAD cohorts, in which different dose levels of sargramostim will be given by intravenous (IV)…
- Trial name
- NCT05366283
- Testing
- sargramostim
- Where
- Canada
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Partner Therapeutics, Inc.
Neoplasms, Liver
A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients With Primary or Metastatic Hepatic Carcinoma
The primary purpose of this study is to determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 (Pexa-Vec) injected within hepatic carcinoma tumors.
- Trial name
- NCT00629759
- Testing
- JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
- Where
- South Korea
- Volunteers
- 14 people
- Sponsor
- Jennerex Biotherapeutics
Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive Cancers
RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from…
- Trial name
- NCT00095862
- Testing
- allogeneic GM-CSF-secreting breast cancer vaccine, recombinant interferon alfa, cyclophosphamide
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Wiseman Research Initiatives LLC
HIV Infections, Cytopenias
A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility
To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have…
- Trial name
- NCT00002006
- Testing
- Zidovudine, Sargramostim
- Where
- United States
- Sponsor
- Sandoz
Coronavirus Disease 2019 (COVID-19) Pneumonia
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in…
- Trial name
- NCT04351152
- Testing
- Lenzilumab, Standard of Care
- Where
- 29 sites in United States, Brazil
- Volunteers
- 520 people
- Sponsor
- Humanigen, Inc.
Acute Myelogenous Leukemia (AML), Multiple Myeloma (MM)
Phase I Study of an Oncofetal Antigen Multi-Peptide Immunotherapy in Subjects With Hematologic Cancer
The study is designed to evaluate safety, immunogenicity, and preliminary anti-tumor activity of a multi-peptide immunotherapy (BB-MPI-03) at three peptide+adjuvant dose levels.
- Conditions
- Acute Myelogenous Leukemia (AML), Multiple Myeloma (MM), Myelodysplastic Syndrome (MDS), Smoldering Multiple Myeloma (sMM)
- Trial name
- BBMPI03 (NCT02240537)
- Testing
- Sargramostim, BB-MPI-03, Montanide
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Benovus Bio, Inc.
Crohn's Disease
Study of Sargramostim in Moderately to Severely Active Crohn's Disease
The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and 6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to assess the efficacy and safety of 6 micro…
- Trial name
- NCT00329537
- Testing
- Sargramostim (Leukine)
- Volunteers
- 11 people
- Sponsor
- Genzyme, a Sanofi Company
Lymphoma
Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
- Trial name
- NCT00089115
- Testing
- autologous immunoglobulin idiotype-KLH conjugate vaccine, rituximab, sargramostim
- Where
- 60 sites in United States
- Sponsor
- Favrille
Dementia Alzheimer's Type
Safety Study of Sargramostim in Treating Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Primary Objective: To compare the effect of repeat doses of Leukine to placebo administered subcutaneously (SC) on established cortical amyloid load in patients with mild cognitive impairment (MCI) due to Alzheimer's disease…
- Trial name
- NCT02667496
- Testing
- Sargramostim GZ402664, Florbetapir F18
- Where
- United States
- Sponsor
- Sanofi
Stage IV Melanoma, Stage III Melanoma
Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
The purpose of this research is to evaluate the safety and effectiveness of tumor cell therapy. This research study is evaluating if a patient-specific experimental therapy for metastatic melanoma will lengthen survival with…
- Trial name
- NCT01875653
- Testing
- Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC), Autologous PBMCs in GM-CSF (MC)
- Where
- 18 sites in United States
- Volunteers
- 4 people
- Sponsor
- Lisata Therapeutics, Inc.
Relapsed/Refractory Large B-cell Lymphoma
Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma
The primary objectives of this study are: Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the most…
- Trial name
- ZUMA-19 (NCT04314843)
- Testing
- Cyclophosphamide, Fludarabine, Lenzilumab
- Where
- 10 sites in United States
- Volunteers
- 6 people
- Sponsor
- Kite, A Gilead Company
Breast Cancer
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of an adjuvant treatment of therapeutic cancer vaccine (AST-301, pNGVL3-hICD) in patients with HER2-low expression (IHC 1+ or 2+ and ISH-) and hormone…
- Trial name
- Cornerstone001 (NCT05163223)
- Testing
- AST-301(pNGVL3-hICD), rhuGM-CSF, Pembrolizumab
- Where
- 17 sites in United States, Taiwan
- Volunteers
- 10 people
- Sponsor
- Aston Sci. Inc.
Autoimmune Pulmonary Alveolar Proteinosis
Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis
This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor [rhGM-CSF]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients.
- Trial name
- IMPALA (NCT02702180)
- Testing
- Molgramostim, PARI eFlow nebulizer system
- Where
- 30 sites in United States, Australia and 16 more
- Volunteers
- 139 people
- Sponsor
- Savara Inc.
Adenocarcinoma of the Prostate
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
The ProVent study is a randomized, open-label study designed to assess the efficacy of sipuleucel-T in reducing the progression of lower risk non-metastatic prostate cancer compared to participants followed on active surveillance…
- Trial name
- ProVent (NCT03686683)
- Testing
- sipuleucel-T
- Where
- 56 sites in United States
- Volunteers
- 532 people
- Sponsor
- Dendreon
Colorectal Cancer
Safety and Immune Response to FMPV-1
This is a single centre, open-label, non-randomized, Phase I study assessing safety and immune response of FMPV-1 in healthy male subjects.
- Trial name
- NCT05238558
- Testing
- FMPV-1, GM-CSF (as adjuvant)
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hubro Therapeutics AS
Malignant Melanoma
Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma
This study, with 20 patients participating, will examine the safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma.
- Trial name
- NCT02275416
- Testing
- Ipilimumab, UV1 vaccine, GM-CSF
- Where
- Norway
- Volunteers
- 12 people
- Sponsor
- Ultimovacs ASA
Lymphoma, Follicular
Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.
- Trial name
- PREMIER (NCT00308087)
- Testing
- Sargramostim (Leukine), Rituximab
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 75 people
- Sponsor
- Genzyme, a Sanofi Company
COVID-19, SARS-CoV-2
Study of Sargramostim in Patients With COVID-19
The purpose of this research is to find out if a drug (sargramostim) also known as Leukine® could help patient recover faster from COVID-19.
- Trial name
- iLeukPulm (NCT04411680)
- Testing
- Sargramostim, Standard of care
- Where
- 11 sites in United States
- Volunteers
- 123 people
- Sponsor
- Partner Therapeutics, Inc.
Breast Cancer
Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients
This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone.
- Trial name
- HER3+ (NCT02297698)
- Testing
- NeuVax vaccine, Trastuzumab, GM-CSF
- Where
- 24 sites in United States
- Volunteers
- 100 people
- Sponsor
- Cancer Insight, LLC
Melanoma
An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended…
- Trial name
- NCT01368276
- Testing
- Talimogene Laherparepvec, Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- BioVex Limited