NCT03022578

Laser Interstitial Thermal Therapy and Lomustine in Treating Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma

Phase II Study of Laser Interstitial Thermal Therapy (LITT) in Recurrent Glioblastoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well laser interstitial thermal therapy and lomustine work in treating patients with glioblastoma or anaplastic astrocytoma that has come back. Using laser to heat the tumor cells may help to kill them. Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving laser interstitial thermal therapy and lomustine may work better in treating patients with glioblastoma or anaplastic astrocytoma.

Detailed description

PRIMARY OBJECTIVES: I. Determine the disease control rate at 6 months in patients with recurrent glioblastoma or isocitrate dehydrogenase (IDH)-wildtype anaplastic astrocytoma treated with Laser Interstitial Thermal Therapy (LITT) at recurrence, followed by salvage chemotherapy. SECONDARY OBJECTIVES: I. Estimate overall survival (OS) of patients with recurrent glioblastoma, or isocitrate dehydrogenase (IDH)-wildtype anaplastic astrocytoma treated with LITT at tumor recurrence, followed by salvage chemotherapy. II. Estimate time to progression (TTP) of patients with recurrent glioblastoma, or isocitrate dehydrogenase (IDH)-wildtype anaplastic astrocytoma that are treated with LITT at tumor recurrence, followed by salvage chemotherapy. III. Analyze volumetric data consisting of thermal damage threshold lines and overall tumor volume to determine any role of 'extent of ablation' in outcomes (OS and/or TTP). IV. Characterize the safety profile of LITT followed by treatment with lomustine chemotherapy in the recurrent disease setting, using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. V. Assess the long-term steroid requirements following LITT, compared to historical controls. VI. Determine the radiographic evolution of LITT-treated glioblastoma over time, using conventional magnetic resonance imaging (MRI) (T1 pre and post-contrast images, T2-weighted images \[T2WI\], fluid attenuating inversion recovery \[FLAIR\] images) and advanced brain tumor imaging (ABTI) \[magnetic resonance (MR) perfusion \[dynamic susceptibility contrast (DSC), dynamic contrast enhancement (DCE) and arterial spin labeling (ASL)\], MR-diffusion, and MR spectroscopy), to include quantitative tumor metrics (volumetric extent of ablation and Response Assessment in Neuro-Oncology \[RANO\] criteria). VII. Analyze health care utilization as measured by length of hospital stay following LITT (including inpatient rehabilitation care). VIII. Evaluate patients' functional status (using the Karnofsky performance score \[KPS\] and the occurrence of symptoms \[using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT\[English\])\] self-reporting tool), and correlate to disease progression and tolerance to treatment. EXPLORATORY OBJECTIVES: I. Identify correlative tumor and peripheral blood molecular markers that impact outcomes, etc, and identify inflammatory/immunologic markers to assess neoantigen expression, etc, if sufficient tissue is available. II. Identify and characterize changes in tumor tissue following LITT, by analyzing and comparing pre- and post-procedure tissue samples, if sufficient tissue is available. OUTLINE: Patients undergo LITT at baseline and receive lomustine orally (PO) on day 1. Treatment with lomustine repeats every 42 days for up to 6 cycles in the absence of disease progression or unaccepted toxicity. After completion of study treatment, patients are followed up every 3 months.

Conditions

• IDH Family Wildtype
• Recurrent Anaplastic Astrocytoma
• Recurrent Glioblastoma

Interventions

Type	Name	Description
PROCEDURE	Laser Interstitial Thermal Therapy	Undergo LITT
DRUG	Lomustine	Given PO

Timeline

• Start date: 2017-11-07
• Primary completion: 2021-02-16
• Completion: 2021-02-16
• First posted: 2017-01-16
• Last updated: 2022-08-10
• Results posted: 2022-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study