Leptomeningeal Metastases Clinical Trial
Official title:
A Phase I/II Clinical Study of Sacituzumab Govitecan Combined With Intrathecal Chemotherapy for the Treatment of Leptomeningeal Metastases From Her2-negative Breast Cancer
Leptomeningeal metastases is a specific pattern of central involvement in which tumor cells invade and proliferate in the subarachnoid space, and is a lethal complication of malignant tumors. Leptomeningeal metastases from Her2-negative breast cancer is still tricky to treat at present, with an overall median survival of only 3-6 months, even after aggressive treatment. This study is an open, uncontrolled phase I/II clinical study to observe the safety, feasibility, and potential efficacy of Sacituzumab Govitecan combined with pemetrexed intrathecal chemotherapy in the treatment of patients with Her2-negative breast cancer leptomeningeal metastases in search of a more effective treatment.
This study is a single-arm prospective phase I/II clinical trial to observe the safety, feasibility, and potential efficacy of Sacituzumab Govitecan combined with pemetrexed intrathecal chemotherapy in the treatment of patients with Her2-negative breast cancer leptomeningeal metastases. Patients were treated with Sacituzumab Govitecan 10mg/kg, infused intravenously on days 1 and 8. Treatment cycles were every 21 days and continued until disease progression or unacceptable toxicity. Pemetrexed intrathecal chemotherapy was initiated on Day 2 after Sacituzumab Govitecan administration. Pemetrexed intrathecal chemotherapy is administered by intracerebroventricular or lumbar puncture. Pemetrexed intrathecal chemotherapy is divided into induction, consolidation and maintenance phases. Induction therapy was first performed with a single dose of 15 mg twice a week for 2 weeks for a total of 4 doses. This was followed by consolidation therapy, 1 time per week for 4 consecutive weeks for a total of 4 times. Patients whose treatment was evaluated as effective were given maintenance therapy once a month until relapse or death. A minimum of 3 patients and a maximum of 6 patients were recruited into the phase I cohort. When dose-limiting toxicity occurred in ≥2 patients, the treatment regimen was considered to be excessively side-effective, and a reduction in the intrathecal chemotherapy dose of pemetrexed to a single 10-mg dose was given, with continued enrollment of 6 consecutive patients. If DLT occurred again in ≥2 patients, the trial would be stopped. Otherwise, the study entered a phase II trial when DLT occurred in ≤1 patient. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01438021 -
Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease
|
N/A | |
| Completed |
NCT02616393 -
Phase 2 Study of Study of Tesevatinib in Subjects With NSCLC and Brain or Leptomeningeal Metastases
|
Phase 2 | |
| Completed |
NCT03101579 -
Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From Non-small Cell Lung Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03719768 -
Avelumab With Radiotherapy in Patients With Leptomeningeal Disease
|
Phase 1 | |
| Terminated |
NCT00005812 -
Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
|
Phase 2 | |
| Terminated |
NCT03661424 -
BATs in Patients With Breast Cancer and Leptomeningeal Metastases
|
Phase 1 | |
| Active, not recruiting |
NCT05289908 -
Intrathecal Pemetrexed for Leptomeningeal Metastasis
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05184816 -
A Study of Deferoxamine (DFO) in People With Leptomeningeal Metastasis
|
Phase 1 | |
| Not yet recruiting |
NCT03613181 -
ANG1005 in Leptomeningeal Disease From Breast Cancer
|
Phase 3 | |
| Terminated |
NCT03275402 -
131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
|
Phase 2/Phase 3 | |
| Completed |
NCT01645839 -
Interest of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Meningeal Metastasis of Breast Cancer
|
Phase 3 | |
| Completed |
NCT03520504 -
Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases
|
Phase 1 | |
| Completed |
NCT00992602 -
Liposomal Cytarabine and High-Dose Methotrexate in Treating Patients With Central Nervous System Metastases From Breast Cancer
|
Phase 2 | |
| Completed |
NCT00005811 -
Topotecan Hydrochloride in Treating Children With Meningeal Cancer That Has Not Responded to Previous Treatment
|
Phase 2 | |
| Active, not recruiting |
NCT04343573 -
Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors
|
Phase 2 |