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Study on Early Immunotherapy with Human Normal Immunoglobulin, Cyclophosphamide, and Methylprednisolone for Patients with Anti-Hu Paraneoplastic Sensory Neuropathy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as paraneoplastic sensory neuropathy with anti-Hu antibodies. This is a rare disorder where the body's immune system mistakenly attacks its own nerve cells, often associated with cancer. The study aims to evaluate the effectiveness of an early treatment approach using a combination of medications: intravenous immunoglobulin, Cyclophosphamide, and Methylprednisolone. These medications are administered through a vein to help manage the symptoms and potentially improve the condition.

The purpose of the study is to assess how well this treatment works over a period of three months. Participants will receive the medications and be monitored for any changes in their symptoms. The study will track improvements in nerve function and overall health, as well as any side effects from the treatment. The medications used in this study are known to help modulate the immune system and reduce inflammation, which may be beneficial for patients with this type of neuropathy.

Throughout the study, participants will be regularly evaluated to see if there is any improvement in their condition. The study will also look at how well patients tolerate the treatment and whether it helps in reducing symptoms like pain and difficulty with movement. The ultimate goal is to find an effective treatment strategy for those affected by this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of paraneoplastic sensory neuropathy with anti-Hu antibodies, and recent onset of symptoms.

    Informed consent is required, which involves understanding the study's purpose and agreeing to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current state of the condition using various scales, such as the Overall Neuropathy Limitations Scale (ONLS) and the modified Rankin Score (mRS).

    This assessment helps establish a baseline for future comparisons.

  3. Step 3

    Treatment phase

    The treatment involves the administration of several medications through intravenous infusion.

    The medications include human normal immunoglobulin, cyclophosphamide, and methylprednisolone. Each is administered according to a specific schedule and dosage.

    The treatment aims to evaluate the efficacy of early immunotherapy in improving symptoms.

  4. Step 4

    Follow-up assessments

    Follow-up assessments occur at 3 and 6 months to measure clinical improvement using the ONLS, Score of Ataxia, and other relevant scales.

    These assessments help determine the effectiveness of the treatment and any changes in the condition.

  5. Step 5

    Monitoring and evaluation

    Throughout the trial, monitoring for any adverse effects of the treatment is conducted to ensure safety.

    The tolerability of the treatment is assessed by recording the frequency and severity of any side effects.

  6. Step 6

    Completion of the trial

    The trial concludes with a final evaluation of the patient's condition and any improvements observed.

    The primary endpoint is the percentage of patients showing clinical improvement at 3 months, with secondary endpoints evaluated at both 3 and 6 months.

Who can join the trial?

9 criteria

  • Adult patients with **anti-Hu antibody paraneoplastic sensory neuropathy**. This means the patient has a specific type of nerve problem related to cancer, with certain antibodies present.
  • Age **18 years or older**.
  • Have a "possible" **sensory neuropathy** according to specific medical criteria. Sensory neuropathy is a condition where nerves that sense touch, temperature, and pain are affected.
  • Have a dominant picture of **sensitive ataxia**. This means there is a noticeable problem with coordination due to nerve issues, but it should not severely affect the patient's ability to function.
  • **Positive anti-Hu antibodies** in blood and/or cerebrospinal fluid. These are specific proteins that the body makes in response to certain conditions.
  • Be an **outpatient** with a Modified Rankin Score (mRS) of 2 or 3. This score measures the level of disability, with 2 or 3 indicating moderate disability but still able to manage daily activities.
  • **Start of neurological symptoms** less than 3 months ago. This means the nerve-related symptoms began recently.
  • Provide **informed consent** that is free, written, and signed. This means the patient agrees to participate after understanding the study details.
  • Be **registered with a social security scheme** or be a beneficiary, except for a specific program called AME.

Who cannot join the trial?

3 criteria

  • Patients who do not have paraneoplastic sensory neuropathy with anti-Hu antibodies cannot participate. This is a condition where the body's immune system mistakenly attacks its own nerves, often associated with cancer.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the exact ages are not specified here.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, like children or those unable to make decisions for themselves, are not included.
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Investigated drugs

  • Intravenous Immunoglobulin

    is a therapy that involves giving patients a mixture of antibodies through a vein. This treatment is used to help boost the immune system and is being tested for its effectiveness in treating nerve damage associated with certain cancers.

  • Cyclophosphamide

    is a medication that suppresses the immune system. It is often used in cancer treatment and is being studied for its potential to help reduce nerve damage in patients with specific immune-related conditions.

  • Methylprednisolone

    is a type of steroid that reduces inflammation in the body. In this trial, it is being used to see if it can help decrease nerve damage and improve symptoms in patients with nerve issues related to cancer.

What is already known about the treatment

  • Intravenous Immunoglobulin

    This medication is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream. It is currently being studied for its effectiveness in treating paraneoplastic sensory neuropathy with anti-Hu antibodies. The main therapeutic use is to modulate the immune system, helping to reduce inflammation and autoimmune activity. At the molecular level, it works by providing antibodies that can neutralize harmful substances in the body. It is classified as an immunomodulatory agent.

  • Cyclophosphamide

    This medication is given intravenously, allowing it to enter the bloodstream directly. It is being investigated for its role in treating paraneoplastic sensory neuropathy with anti-Hu antibodies. Its primary therapeutic indication is to suppress the immune system, which can help in conditions where the immune system is attacking the body's own tissues. Cyclophosphamide works by interfering with the DNA of rapidly dividing cells, including immune cells, thus reducing their activity. It is classified as an immunosuppressant and chemotherapy agent.

  • Methylprednisolone

    Administered intravenously, this medication is delivered directly into the bloodstream. It is under study for its potential benefits in treating paraneoplastic sensory neuropathy with anti-Hu antibodies. The main therapeutic use is to reduce inflammation and suppress the immune response. At the molecular level, it works by mimicking the effects of hormones produced by the adrenal glands, which help to decrease inflammation and immune activity. It is classified as a corticosteroid.

Investigated diseases

Paraneoplastic Sensory Neuropathy with Anti-Hu Antibodies – This is a rare neurological disorder that occurs when the body's immune system mistakenly attacks its own nerve cells, often in association with cancer. It primarily affects the sensory nerves, leading to symptoms such as numbness, tingling, and pain, typically starting in the hands and feet. As the condition progresses, it can cause more widespread sensory disturbances and may affect balance and coordination. The presence of anti-Hu antibodies is a key feature, indicating an immune response linked to an underlying tumor. The progression of symptoms can vary, and they may develop rapidly or gradually over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506942-22-01Protocol codeAPHP230701Estimated enrolment21 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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