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RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Colony-stimulating factors, such as sargramostim (GM-CSF), may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet know whether giving ipilimumab together with GM-CSF is more effective than ipilimumab alone in treating melanoma.
PURPOSE: This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
- To evaluate the overall survival of patients with advanced melanoma treated with ipilimumab with versus without sargramostim.
- To evaluate the progression-free survival of patients treated with these regimens.
- To evaluate the response rate in patients treated with these regimens.
- To evaluate the safety and tolerability of these regimens in these patients.
- To explore prospectively the utility of immune-related response criteria (irRC) of patients receiving ipilimumab.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (unresectable vs M1a/1b vs M1c) and prior therapy (none vs interferon vs one investigational therapy). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive induction therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 courses. Patients with responsive or stable disease then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive induction therapy comprising ipilimumab as in arm I. Patients with responsive or stable disease then receive maintenance therapy comprising ipilimumab IV as in arm I. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3-6 months for up to 5 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:13:16-0400
RATIONALE: Inhaling sargramostim may interfere with the growth of tumor cells and may be an effective treatment for melanoma that has spread to the lung. PURPOSE: This phase I trial is st...
RATIONALE: Colony-stimulating factors, such as sargramostim, may help the body's immune system to kill cancer cells. Giving sargramostim in different ways may kill more cancer cells. ...
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone ma...
The purpose of this study is to determine whether the sequence of 6 wk vemurafenib followed by ipilimumab monotherapy has an acceptable safety profile with regards to the skin
A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma
Ipilimumab is approved for the treatment of advanced melanoma in adults; however, little information on the efficacy and safety of ipilimumab in younger patients is available.
Ipilimumab is a CTLA-4 monoclonal antibody that amplifies T-cell activation and response to melanoma. It is approved to treat unresectable or metastatic melanoma. Immune-related adverse events are com...
Analysis of survival of patients treated with vemurafenib, ipilimumab and dabrafenib for advanced skin melanoma in daily clinical practice (Real-World Data): retrospective analysis of patients treated under drug/reimbursement programmes in Poland in 2013-2016.
Vemurafenib, ipilimumab and dabrafenib were registered for the treatment of advanced skin melanoma pursuant to the results of randomized phase III clinical trials. Real-world data on survival time for...
Ipilimumab and Nivolumab are novel monoclonal antibodies that have recently been used successfully for treatment of metastatic melanoma. Ipilimumab is a human monoclonal antibody against Cytotoxic T L...
Immune checkpoint therapy has dramatically changed treatment options in patients with metastatic melanoma. However, a relevant part of patients still does not respond to treatment. Data regarding the ...
An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)
A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.
Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)
Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.
Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...
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