A Pilot Phase 1 Study of Intrathecal Pemetrexed for Refractory Leptomeningeal Metastases From Non-small-cell Lung Cancer.
Zhenyu Pan, Guozi Yang, Jiuwei Cui...
https://pubmed.ncbi.nlm.nih.gov/31544065Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
ID06762080
Intrathecal Administration of PD-1/CTLA-4 Bispecific Antibody Plus Pemetrexed in Patients With Leptomeningeal Metastasis From Solid Tumors: A Phase I/II Study
Led by Guangzhou Medical University · Updated on 2025-05-20
36
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Leptomeningeal metastasis is a serious condition where tumor cells spread and grow in the fluid-filled space surrounding the brain and spinal cord, often seen in advanced cancers. This research is a Phase I/II clinical trial evaluating a combination of intrathecal (spinal fluid) administration of a PD-1/CTLA-4 bispecific antibody with pemetrexed to determine the best dose, safety, and treatment response in patients with this condition. The study aims to find effective treatment options for this fatal complication and is led by Guangzhou Medical University. Participants receive the experimental treatment consisting of cadonilimab, a PD-1/CTLA-4 bispecific antibody given by injection into the spinal fluid every two weeks for six weeks during induction, then monthly during maintenance until disease progression or death. Pemetrexed is also administered intrathecally, starting with twice-weekly doses for two weeks, followed by once-weekly doses for four weeks, then monthly maintenance doses until the patient’s condition worsens or intolerable side effects occur. The study includes dose finding and safety monitoring phases. Throughout the study, patients undergo regular cerebrospinal fluid and blood sample collection to investigate markers that might predict treatment effects and safety. Researchers monitor treatment response, progression-free survival, overall survival, and any adverse events for up to six months after starting treatment. The total study duration allows for ongoing assessment of safety and effectiveness of this combination therapy in leptomeningeal metastasis patients.
CONDITIONS
Brief Title
Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of solid tumors with positive cerebrospinal fluid cytopathology
- Male or female aged between 18 and 75 years
- Normal liver and kidney function
- White blood cell count ≥ 4000/mm3
- Platelet count ≥ 100000/mm3
- No history of severe nervous system disease
- No severe blood disorders (dyscrasia)
You will not qualify if you...
- Evidence of nervous system failure including severe encephalopathy or Glasgow Coma Score less than 11
- Grade 3 or 4 leukoencephalopathy on imaging
- Extensive and lethal progressive systemic diseases without effective treatment
- History of HIV or AIDS, acute or chronic hepatitis B or C infection
- Previous anti-PD1 therapy-induced pneumonitis or ongoing adverse events from such therapy
- Ongoing autoimmune disease requiring systemic treatment within the past 2 years
- Use of new drugs effective against leptomeningeal metastases within the first month and during induction and consolidation phases, excluding previously administered therapies
- Poor compliance or other reasons making the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Until leptomeningeal metastasis progression, death, or intolerable adverse events
Participants receive intrathecal injections of PD-1/CTLA-4 bispecific antibody every two weeks for six weeks during the induction phase, then monthly during maintenance. Pemetrexed is given twice per week for 2 weeks in induction, once per week for 4 weeks in consolidation, and once per month in maintenance, continuing until disease progression, death, or intolerable side effects.
Twice weekly visits for 2 weeks, weekly visits for 4 weeks, then monthly visits thereafter
Trial Site Locations
Total: 1 location
1
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, Guangdong, China, 516000
Actively Recruiting
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Research Team
Z
Zhenyu Pan, PhD, MD
G
Guozi Yang, PhD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Concurrent intrathecal and intravenous nivolumab in leptomeningeal disease: phase 1 trial interim results.
Isabella C Glitza Oliva, Sherise D Ferguson, Roland Bassett...
https://pubmed.ncbi.nlm.nih.gov/36997799