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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

  1. Add the dataset to your request by clicking 'Add to Request' button below. You may add dataset(s) with up to 5 clinical trials in a single request.
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Multiple Myeloma

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma

Unique Dataset IDnci-data-68
DownloadableNo
SponsorNational Cancer InstituteData ProviderNational Cancer InstituteTotal Study Enrolled Patients815RandomizationYesPubMed (PMID)26351350.00ClinicalTrial.gov IDNCT01989572ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT01989572
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataN/AIntervention TypePlacebo, BiologicalDataset TypeOther

NCI Description

There are two different submissions (each with one dataset) for trial NCT01989572. This dataset, NCT01989572-D2, contains toxicity data. The other dataset, NCT01989572-D1, contains baseline and efficacy data.

Clinical Trial Title

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma

Trial Summary and Conditions

This randomized phase III trial studies sargramostim (Granulocyte-macrophage colony-stimulating factor, GM-CSF) or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with locally advanced or stage IV melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare overall survival and recurrence-free survival of patients with completely resected stage IV melanoma or stage III melanoma with gross extranodal extension, satellites, and/or intransit lesions, treated with granulocyte macrophage colony-stimulating factor (GM-CSF) (sargramostim) vs. no GM-CSF, or other high risk patients listed in the eligibility section. SECONDARY OBJECTIVES: I. To compare, using a 2 x 2 factorial design, overall survival and recurrence-free survival of human leukocyte antigen (HLA)-A2 positive patients treated with peptide vaccination vs. no peptide vaccination. II. The following descriptive evaluations of survival and recurrence-free survival are planned for the HLA-A2 positive patients: (1) GM-CSF plus peptide vaccination vs. peptide vaccination alone; (2) GM-CSF plus peptide vaccination vs. GM-CSF alone; (3) GM-CSF plus peptide vaccination vs. placebo. III. Survival and recurrence-free survival of HLA-A2 positive patients not receiving peptide vaccination will be compared to that of HLA-A2 negative patients not receiving peptide vaccination. IV. To determine the influence of GM-CSF on circulating dendritic cell numbers and subpopulations in peripheral blood of patients receiving and not receiving GM-CSF. V. To determine, in HLA-A2 positive patients, whether immunization with peptides with or without GM-CSF elicits a measurable T-cell response as assessed by enzyme-linked immunosorbent spot (ELISPOT) and the major histocompatibility complex (MHC) tetramer assay, and to determine the functionality of these cells by intracellular cytokine staining.

Outcome Measures

Primary: Overall Survival [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] Recurrence Free Survival [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] Secondary: Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15 ] Recurrence Free Survival in HLA-A2 Positive Patients [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] 5-year Overall Survival Rate [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] 5-year Recurrence Free Survival Rate [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01989572-D2-Data-Dictionary.pdf

DATA: NCT01989572-D2-Dataset.csv

OTHER: README.pdf