Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT03101579 |
Recruitment Status :
Completed
First Posted : April 5, 2017
Last Update Posted : March 19, 2019
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Condition or disease | Intervention/treatment | Phase |
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Leptomeningeal Metastases | Drug: Pemetrexed Drug: Dexamethasone Drug: Folic Acid Drug: Vitamin B12 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastasis From Non-small Cell Lung Cancer: A Prospective Pilot Clinical Trial |
Actual Study Start Date : | March 1, 2017 |
Actual Primary Completion Date : | September 15, 2018 |
Actual Study Completion Date : | January 5, 2019 |

Arm | Intervention/treatment |
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Experimental: Intra-pemetrexed
Patients were treated with intrathecal pemetrexed at dose escalation. The regimen of intrathecal pemetrexed is 10/15/20 mg, plus dexamethasone 5 mg, twice per week for 2 weeks, followed by once per week for 2-4 weeks. Pemetrexed is administrated by intrathecal injection via lumbar puncture. Folic acid 200-400 μg is administered orally once daily, prior to the first intrathecal pemetrexed, until 21 days after the last intrathecal pemetrexed. A single dose of vitamin B12 1000 μg is administered by intramuscular injection before the first intrathecal pemetrexed,once per 3 weeks. To detect the pharmacokinetics of intrathecal pemetrexed, the serum and cerebrospinal fluid samples are collected. These samples would be analyzed by spectrometer for drug concentration.
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Drug: Pemetrexed
Pemetrexed,10-15 mg, intrathecal injection via lumbar puncture, twice per week for 2 weeks, followed by once per week for 2-4 weeks. Drug: Dexamethasone Dexamethasone, 5 mg, intrathecal injection via lumbar puncture, simultaneously with pemetrexed, twice per week for 2 weeks, followed by once per week for 2-4 weeks. Drug: Folic Acid Folic acid, 400 μg, oral, once per day, prior to the first intrathecal pemetrexed, until 21 days after the last intrathecal pemetrexed. Drug: Vitamin B12 A single dose of vitamin B12 1000 μg, intramuscular injection, before the first intrathecal pemetrexed. |
- Incidence of severe adverse events [ Time Frame: Two months after the treatment. ]Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0). Events of grade 3-5 are defined as moderate and severe adverse events.
- Maximal tolerated dose [ Time Frame: From the beginning of the treatment until two months after the treatment. ]A dose-limiting toxicity (DLT) was defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicity. If more than two patients experienced a DLT, that level was considered too toxic. The maximal tolerated dose (MTD) was exceeded and an additional three patients should be treated at the next lower dose level. The MTD was defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose.
- Clinical response rate [ Time Frame: One month after the treatment. ]The RANO proposal for response criteria of leptomeningeal metastasis was used to assess the clinical response in this study.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients diagnosed as leptomeningeal metastases from non-small cell lung cancer had been received comprehensive treatment, including intrathecal methotrexate and/or cytarabine, central nervous system radiation therapy, systemic chemotherapy as well as tyrosine-kinase inhibitor drugs.
- Patients diagnosed with recurrent leptomeningeal metastases by positive cerebrospinal fluid cytological examination and persist aggravate symptoms for more than 1 week, or increased intracranial pressure (>300 mmH2O).
- No severe abnormal liver and kidney function; WBC≥2500/mm3, Plt≥60000/mm3;
- No other severe chronic diseases;
- No severe dyscrasia.
- Signed informed consent form.
Exclusion Criteria:
- Patients with the clinical manifestation of nervous system failure including severe encephalopathy, grade III-IV white matter lesions confirmed by imaging examination, moderate or severe coma, and glasgow coma score less than 9 points;
- Patients with severe nervous system injury related with treatment, such as chemical meningitis;
- Patients who had accepted systemic chemotherapy within two weeks, or new molecular targeted therapeutic drug less than one months;
- Patients with poor compliance, or for other reasons, the researchers considered unsuitable to participate in this clinical study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101579
China, Jilin | |
The First Hospital of Jilin University | |
Changchun, Jilin, China, 130021 |
Principal Investigator: | Zhenyu Pan, Professor | The First Hospital of Jilin University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Zhenyu Pan, Professor, The First Hospital of Jilin University |
ClinicalTrials.gov Identifier: | NCT03101579 |
Other Study ID Numbers: |
IPRLM |
First Posted: | April 5, 2017 Key Record Dates |
Last Update Posted: | March 19, 2019 |
Last Verified: | March 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Leptomeningeal metastasis Recurrence Intrathecal chemotherapy Pemetrexed |
Neoplasm Metastasis Neoplasms, Second Primary Meningeal Carcinomatosis Neoplasms by Site Neoplasms Neoplastic Processes Pathologic Processes Meningeal Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Nervous System Diseases Folic Acid Vitamin B 12 Hydroxocobalamin Dexamethasone |
Pemetrexed Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |