Concurrent Intrathecal-pemetrexed and Involved-field Radiotherapy for Leptomeningeal Metastasis From Solid Tumors
Condition: Leptomeningeal Metastasis
MeSH terms: Neoplasm Metastasis; Meningeal Carcinomatosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Intrathecal chemotherapy is one of the most important treatment modalities for leptomeningeal
      metastasis of solid tumors. In the previous retrospective study, it has been proved that
      concurrent radiotherapy and intrathecal methotrexate for leptomeningeal metastasis from solid
      tumors with adverse prognostic factors showed great effectiveness and safety. The preliminary
      results of investigators' current prospective clinical study (Involved-field Radiotherapy
      Combined With Concurrent Intrathecal-methotrexate Versus Intrathecal-Ara-C for Leptomeningeal
      Metastases From Solid Tumor: A Randomized Phase II Clinical Trial. ClinicalTrials.gov
      identification number: NCT03082144) also showed that the regimen of concurrent intrathecal
      chemotherapy and radiotherapy may serve as an optimal therapeutic option for treatment of
      leptomeningeal metastases from solid tumors. Pemetrexed is a newer multitargeted antifolate
      which has shown activity in various tumors. In investigators' current study (Intrathecal
      Pemetrexed for Recurrent Leptomeningeal Metastasis From Non-small Cell Lung Cancer: A
      Prospective Pilot Clinical Trial. ClinicalTrials.gov identification number: NCT03101579), the
      regimen of intrathecal pemetrexed with folic acid and vitamin B12 supplementation may provide
      higher effectiveness and safety for recurrent leptomeningeal metastasis from non-small cell
      lung cancer. Therefore, the purpose of the study is to evaluate the tolerability, safety and
      effectiveness of intrathecal pemetrexed combined with involved-field radiotherapy as the
      first line treatment in patients with leptomeningeal metastases from malignant solid tumors.
    

Detailed description: 
      This study is a single arm, open clinical trial. Consecutive patients with leptomeningeal
      metastases from malignant solid tumors are enrolled into this study. Concomitant regimen
      consisted of intrathecal chemotherapy (via lumbar puncture, pemetrexed 10 mg, plus
      dexamethasone 5 mg, once per week, 5 to 8 times, 4 to 7 weeks in total) and radiotherapy.
      Radiotherapy consisted of fractionated, conformal radiation given at a daily dose of 2 Gy.
      The planning volume consisted of sites of symptomatic disease, bulky disease observed on
      magnetic resonance imaging(MRI), including the whole brain and basis cranii received 40 Gy in
      20 fractions, 4 weeks in total, and/or segment of spinal canal received 40-50 Gy. The RANO
      proposal for response criteria of leptomeningeal metastasis was used to assess the clinical
      response in this study.
    

Intervention name(s): Pemetrexed; Dexamethasone; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Pemetrexed, 10 mg,intrathecal injection, plus dexamethasone 5 mg, once per week, 5 to 8 times, 4 to 7 weeks in total.; Dexamethasone, 5 mg, intrathecal injection, simultaneously with pemetrexed, once per week, 5 to 8 times, 4 to 7 weeks in total.; The sites of symptomatic disease, bulky disease observed on MRI, including the whole brain and basis cranii, 40 Gy in 20 fractions;and/or segment of spinal canal received 40-50 Gy in 20-25 fractions.
Intervention MeSH terms: Dexamethasone; Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leptomeningeal metastasis; Malignant solid tumors; Pemetrexed; Intrathecal chemotherapy; Radiotherapy