Hippocampal avoidance during craniospinal irradiation for breast and lung cancer with leptomeningeal metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial investigates the effectiveness of craniospinal irradiation (CSI) with hippocampal avoidance in patients suffering from leptomeningeal metastases due to breast cancer or non-small cell lung cancer. The study employs proton therapy or volumetric modulated arc therapy (VMAT) to target tumor cells while minimizing radiation exposure to the hippocampus, which is crucial for memory and cognitive function. Patients will receive treatment once daily for 10 days and will be monitored through various imaging techniques and follow-ups for up to a year. The goal is to relieve symptoms caused by the metastases while reducing neurological side effects associated with traditional radiation therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases established radiographically and/or through CSF cytology
* Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases
* Patients ≥ 18 years old
* Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) ≥ 2
* The patient is able to provide informed consent
* Hemoglobin \> 8 g/dL
* Absolute neutrophil count \> 1,000/mm
* Platelet count \> 100,000/mm
* Participants born female at birth must either be of non-reproductive potential (i.e. post-menopausal by history \[≥ 60 years old, or with no menses for \> 1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum /urine pregnancy test within 3 weeks prior to starting radiation therapy (RT)
* Patients with reproductive potential must agree to practice two highly effective contraceptive methods

Exclusion Criteria:

* Patients with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
* Patients with extensive systemic disease and without reasonable systemic treatment options
* Patients who are unable to undergo MRI brain and spine with gadolinium contrast
* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
* Gross ventricular disease
* Brain metastases within 5 mm of the hippocampal contours not previously treated
* Pregnant or lactating women

Where it's running

• Laura and Isaac Perlmutter Cancer Center at NYU Langone
  New York, New York, United States Recruiting
• Fred Hutch/University of Washington Cancer Consortium
  Seattle, Washington, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Not yet recruiting

Study contacts

• Principal investigator: Lia M. Halasz — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Lia M. Halasz
• Email: lhalasz@uw.edu
• Phone: 206-897-2121

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Photon VMAT craniospinal radiation for leptomeningeal disease from breast or non‑small cell lung cancer

  This trial tests whether craniospinal irradiation delivered with photon VMAT can help adults whose breast cancer or non‑small cell lung cancer has spread to the meninges (leptomeningeal disease).

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT06910761

• Comparing proton radiation therapy to standard radiation for leptomeningeal metastasis

  This study is testing whether proton radiation therapy is better than standard radiation for people with leptomeningeal metastasis from breast or lung cancer to see if it helps them live longer and stay healthier.

  Recruiting at 58 sites Phase 3 NRG Oncology · Phoenix, Arizona and 57 other locations · NCT06500481

• Using electric fields to treat spinal cancer spread in breast cancer patients

  This study tests if wearing a portable device that uses electric fields can help breast cancer patients whose cancer has spread to the spine feel better and slow down tumor growth.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT05746325

• Personalized vaccine combined with pembrolizumab for advanced solid tumors

  This study is testing a new personalized cancer vaccine combined with pembrolizumab to see if it helps people with advanced solid tumors fight their cancer better.

  Recruiting Phase 1/2 Mayo Clinic · Jacksonville, Florida · NCT05269381

• Personalized vaccine treatment for advanced melanoma, breast cancer, and lung cancer

  This study is testing a personalized vaccine combined with a treatment called nivolumab to see if it can help people with advanced melanoma, breast cancer, or lung cancer fight their tumors better.

  Recruiting Phase 1 Fred Hutchinson Cancer Center · Seattle, Washington · NCT05098210

• Couples Coping Together Against Cancer: A Feasibility and Acceptability Look

  This observational study tests whether a brokered program for patients with cancer and their partners is feasible and acceptable, and whether it may reduce distress over time.

  Recruiting City of Hope Medical Center · Duarte, California · NCT07664579

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.