A study to compare tyrosine kinase inhibitor versus tyrosine kinase inhibitor with intrathecal methotrexate in lung cancer patients with brain metastasis

Not Applicable

• Conditions: Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified

• Registration Number: CTRI/2022/01/039501
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects must have leptomeningeal metastasis from a driver mutated NSCLC. The diagnosis of LMM will be based on EANO criteria16. Patients with either confirmed or probable LMM disease status will be included in this study

2. Age: Male or female subjects aged = 18 years.

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3.

4. Subjects must have normal organ and marrow function as per TMH

5. Patients with HIV are potentially eligible, as long as they have a CD4 count > 200, are on concurrent HAART (highly active antiretroviral therapy), and have absence of active AIDS defining conditions.

6. Both men and women of all races and ethnic groups are eligible for this study.

7. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments.

8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Subjects who are receiving any other investigational agents.

2. Within 2 weeks of administration of a chemotherapeutic agent.

3. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) d. Steroids for raised intracranial pressure due to the disease itself e,Steroid use for avoidance or treatment of emesis.

4. Active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.

5. Prior organ transplantation including allogeneic stem-cell transplantation.

6. Active infection requiring systemic therapy.

7. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v4.03 Grade = 3).

8. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke ( < 6 months prior to enrollment), myocardial infarction ( < 6 months prior to enrollment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.

9. Pregnant and lactating women are excluded from this study.

10. Local site infection making it infeasible for lumbar puncture

11. Persistent features of raised intracranial pressure which has not subsided post steroids, mannitol and other decongesting interventions thus ruling out option of lumbar puncture

Study & Design

• Study Type: Interventional
• Study Design: Not specified