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Report for Clinical Trial NCT01014546

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I Study of Oral Arsenic Trioxide With or Without Ascorbic Acid in Adults With Myelofibrosis

This phase I trial studies the side effects and best dose of arsenic trioxide with or without ascorbic acid in treating patients with myelofibrosis. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving arsenic acid together with ascorbic acid may kill more cancer cells.

NCT01014546 Essential Thrombocythemia Polycythemia Vera Primary Myelofibrosis
MeSH:Polycythemia Vera Primary Myelofibrosis Polycythemia Thrombocytosis Thrombocythemia, Essential
HPO:Polycythemia Thrombocytosis

4 Interventions

Name: Arsenic Trioxide

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (arsenic trioxide with or without ascorbic acid)

Name: Ascorbic Acid

Description: Given PO
Type: Dietary Supplement
Group Labels: 1

Treatment (arsenic trioxide with or without ascorbic acid)

Name: Laboratory Biomarker Analysis

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (arsenic trioxide with or without ascorbic acid)

Name: Pharmacological Study

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (arsenic trioxide with or without ascorbic acid)


Primary Outcomes

Description: The frequency of toxicities will be tabulated by grade across all dose levels and courses. The frequency of toxicities will also be tabulated for the dose chosen as the MTD.

Measure: Adverse events, and their attribution throughout the study

Time: Up to 30 days post-treatment

Description: DLT is defined as any non-hematologic treatment-emergent grade 3 or greater adverse event deemed possibly, probably, or definitely related to the study drug. Exceptions are grade 3 nausea or vomiting, unless in the setting of maximal antiemetic treatment. Hematologic toxicities are not included in the definition of a DLT. The frequency of toxicities will be tabulated by grade across all dose levels and cycles.

Measure: Dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 (Stage 1)

Time: At 28 days

Description: The frequency of toxicities will be tabulated by grade across all dose levels and cycles. The frequency of toxicities will also be tabulated for the dose chosen as the MTD.

Measure: Maximum tolerated dose (MTD), defined as the dose level at which 0 or 1 of 6 subjects experience DLT, and 2 of 3 or 2 of 6 experience DLT at the next higher dose level, assessed by the NCI CTC version 3.0 (Stage 1)

Time: At 28 days

Secondary Outcomes

Measure: Change in absolute number of circulating CD34+ cells in the peripheral blood (Stage 2 only)

Time: Baseline to 24 weeks

Measure: Change in JAK2/MPL (Stage 2 only)

Time: Baseline to 24 weeks

Description: Including: sVCAM-1, NE, MMP-2, MMP-9, SDF-1, TGF-B, and VEGF.

Measure: Change in plasma levels of chemokines as measured by ELISA (Stage 2)

Time: Baseline to 24 weeks

Description: Including: sVCAM-1, NE, MMP-2, MMP-9, SDF-1, TGF-B, and VEGF.

Measure: Change in plasma levels of cytokines as measured by ELISA (Stage 2)

Time: Baseline to 24 weeks

Description: Including: soluble vascular cell adhesion molecule 1 (sVCAM-1), neutrophil elastase (NE), matrix metalloproteinases 2 and 9 (MMP-2 and MMP-9), stromal cell derived growth factor-1 (SDF-1), TGF-B, and VEGF.

Measure: Change in plasma levels of proteases as measured by enzyme-linked immunosorbent assay (ELISA) (Stage 2)

Time: Baseline to 24 weeks

Measure: Disease response assessed using the IWG-MRT response criteria

Time: Up to 24 weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V617F

To estimate the efficacy of arsenic trioxide with ascorbic acid in subjects with myelofibrosis, as determined by a reduction in Janus kinase 2 (JAK2) V617F, JAK22T875N, and mutations of the thrombopoietin receptor (MPL515L/K) allele frequency in peripheral blood neutrophils. --- V617F ---



HPO Nodes


HPO: