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Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

2014-08-27 03:13:16 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- To evaluate the overall survival of patients with advanced melanoma treated with ipilimumab with versus without sargramostim.

Secondary

- 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.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma (Skin)

Intervention

ipilimumab, sargramostim

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:16-0400

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Medical and Biotech [MESH] Definitions

An anti-CTLA-4 ANTIGEN monoclonal antibody initially indicated for the treatment of certain types of metastatic MELANOMA. Its mode of actions may include blocking of CTLA-4 mediated inhibition of CYTOTOXIC T LYMPHOCYTES, allowing for more efficient destruction of target tumor cells.

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.

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