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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Cevjxt Hxiczrhwrgt Eh Uzhoezuygzgsr Dq Lvoylfl	Limoges	France
Avmzxbvrou Pmsogljl Hzgatilo Dk Mxxxqkcim	Marseille	France
Iobmoqjg df Cjinycxrvazp Hfbmohhkiyr Ujaloppurvidu dh Sbwjt Eytdjup (xgnyryk	Saint Priest En Jarez	France
Hpkhtkka Ussimrjiilhidn Suowudiwvu &nrnxut Hetdkgh db Hynnpguedef	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	10.01.2025

Trial locations

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.

Investigated diseases:

Paraneoplastic neurological syndrome

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 ID:

2023-506942-22-01

Protocol code:

APHP230701

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

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