STAT3 Inhibitor WP1066 in Treating Patients With Recurrent Malignant Glioma or Progressive Metastatic Melanoma in the Brain

  • STATUS
    Recruiting
  • participants needed
    33
  • sponsor
    M.D. Anderson Cancer Center
Updated on 20 September 2021
metastatic melanoma
metastatic disease
measurable disease
BRAF
brain mri
metastasis
neutrophil count
tumor cells
brain metastases
thromboplastin
glioblastoma multiforme
malignant glioma
antiepileptic
recurrent malignant glioma
seizure disorder
anaplastic glioma
immunomodulators
immunologic adjuvant
cytotoxic t-lymphocyte antigen 4

Summary

This phase I trial studies the side effects and best dose of STAT3 inhibitor WP1066 in treating patients with malignant glioma that has come back or melanoma that has spread to the brain and is growing, spreading, or getting worse. STAT3 inhibitor WP1066 may stop the growth of tumor cells and modulate the immune system.

Description

PRIMARY OBJECTIVES; I. Identify the maximum tolerated dose (MTD) of STAT3 inhibitor WP1066 (WP1066) in patients with recurrent malignant glioma (glioblastoma, anaplastic glioma), and melanoma patients with progressive brain metastasis.

II. Assess the safety and tolerability of WP1066 in patients with recurrent malignant glioma and melanoma patients with progressive brain metastasis using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) with special attention directed at determining whether any induced autoimmune reactions occur.

SECONDARY OBJECTIVES:

I. Pharmacokinetic analysis of the in vivo bioavailability of WP1066. II. Assess overall response rate (ORR) in patients with recurrent malignant gliomas and progressive metastatic melanoma to the brain.

III. Assess immunological response in patients with recurrent malignant glioma and melanoma patients with progressive brain metastasis treated with WP1066.

IV. Assess time to radiographically assessed progression and/or response in patients treated with WP1066.

V. Assess progression-free survival (PFS) and overall survival (OS) in patients treated with WP1066.

VI. Estimate the proportion of patients treated with WP1066 who develop additional melanoma metastatic lesions, including those in the central nervous system (CNS).

OUTLINE: This is a dose-escalation study.

Patients receive STAT3 inhibitor WP1066 orally (PO) twice daily (BID) on Monday, Wednesday, and Friday of weeks 1 and 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 and 2 months.

Details
Condition Central Nervous System Neoplasms, melanoma, skin cancer, Malignant neoplasm of brain, Metastatic Melanoma, Brain Tumor (Pediatric), Solid Tumors, Brain Metastasis, Recurrent Malignant Glioma, Metastatic Malignant Neoplasm in the Brain, Brain Metastases, Stage IV Melanoma, Recurrent Glioblastoma, Brain Cancer, Malignant Melanoma, Brain Tumor, recurrent brain tumors
Treatment laboratory biomarker analysis, Surgical Resection, pharmacological study, WP1066, Advanced Brain Tumor Imaging (ABTI), JAK2 Inhibitor WP1066, STAT3 Inhibitor WP1066
Clinical Study IdentifierNCT01904123
SponsorM.D. Anderson Cancer Center
Last Modified on20 September 2021

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