Actively Recruiting

Age: 18Years +
All Genders
ID06399926

Open-label, Randomized Multi-center Prospective Study of Intraventricular Pemetrexed Disodium via Ommaya Reservoir for Leptomeningeal Metastasis in Lung Cancer

Led by Xiangya Hospital of Central South University · Updated on 2024-05-06

64

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

X

Xiangya Hospital of Central South University

Lead Sponsor

F

First People's Hospital of Chenzhou

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research is an open-label, multi-center prospective observational study evaluating the safety and effectiveness of intraventricular pemetrexed disodium administered via an Ommaya reservoir. It focuses on patients with leptomeningeal metastasis from lung cancer who have not responded to at least one targeted therapy, including those who failed third-generation EGFR-TKIs for EGFR-mutated lung cancer, second-generation ALK-TKIs for ALK-mutated lung cancer, or one line of targeted TKIs for ROS1-mutated non-squamous non-small cell lung cancer. Participants are assigned to one of two groups. Cohort 1 receives pemetrexed 20mg every 24 hours for 72 hours every 2 weeks during induction, switching to every 3 weeks during consolidation if remission or stable disease is observed. Cohort 2 receives pemetrexed 30mg once weekly during induction, then every 3 weeks in consolidation. Treatment continues until intolerance or disease progression. A crossover may occur between cohorts based on early comparative evaluation of efficacy and toxicity. Throughout the study, participants undergo regular efficacy assessments every two cycles, including cerebrospinal fluid cytology tests. Monitoring includes evaluation of response rates at 3 months and long-term outcomes like disease control, progression-free survival, overall survival, cytology clearance, and adverse effects over two years. Participants must adhere to scheduled visits, treatments, and laboratory tests as outlined in the protocol during the entire study period.

CONDITIONS

Brief Title

Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of non-squamous non-small cell lung cancer with genetic testing for EGFR, ALK, or ROS1 mutations
  • Diagnosed leptomeningeal metastasis as per CSCO and EANO-ESMO criteria with positive cerebrospinal fluid cytology or meningeal biopsy
  • Failed at least three generations of EGFR-TKIs for EGFR mutations, second-generation ALK inhibitors for ALK mutations, or one line of ROS1 inhibitors
  • No contraindication to Ommaya reservoir implantation
  • Women capable of pregnancy must agree to use reliable contraception during the study; men with partners capable of pregnancy must also agree
  • Ability and willingness to comply with study visits, treatment, and laboratory tests with informed consent signed
Not Eligible

You will not qualify if you...

  • Positive for hepatitis B or C virus with high viral load without effective treatment
  • HIV infection
  • Significant or uncontrolled extracranial disease progression causing severe symptoms
  • Severe cachexia or extreme weight loss
  • Extensive brain lesions with severe symptoms not controlled by treatment
  • Current treatment for other malignant tumors
  • Received or planned live vaccine within 30 days before consent
  • Conditions affecting safety or compliance, including serious heart issues, active infections, severe organ dysfunction, low blood counts, active bleeding, or abnormal liver function
  • Known serious hypersensitivity to pemetrexed
  • Pregnant or breastfeeding women

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Induction Treatment

Duration - Varies until remission or stable disease is confirmed

Participants receive pemetrexed as induction therapy to evaluate efficacy. Cohort 1 receives 20mg every 24 hours for 72 hours every 2 weeks, and Cohort 2 receives 30mg once weekly. Efficacy is evaluated every 2 cycles with additional assessments if results change or to confirm CSF cytology clearance.

Visits every 1 to 2 weeks depending on cohort and assessment schedule

Consolidation Treatment

Duration - Until intolerable toxicity or disease progression

Participants who show remission or stable disease during induction advance to consolidation treatment with pemetrexed. Cohort 1 receives 20mg every 24 hours for 72 hours every 3 weeks, and Cohort 2 receives 30mg once every 3 weeks, continuing until toxicity is intolerable or disease progresses.

Visits every 3 weeks

Trial Site Locations

Total: 1 location

1

Xiangya Hospital Central South University

Changsha, Hunan, China, 410008

Actively Recruiting

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Research Team

B

bin Li, doctor

X

xiangping Li, pharmacist

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

The Comparative Treatment of Intraventricular Chemotherapy by Ommaya Reservoir vs. Lumbar Puncture in Patients With Leptomeningeal Carcinomatosis.

Mariano Montes de Oca Delgado, Bernardo Cacho Díaz, José Santos Zambrano...

https://pubmed.ncbi.nlm.nih.gov/30524956