Study on Retinoblastoma Treatment Using Etoposide, Carboplatin, and Melphalan for Patients with Specific Eye Conditions

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What is this study about?

This clinical trial focuses on the conservative treatment of patients with retinoblastoma, a rare type of eye cancer that typically affects young children. The study involves several medications, including etoposide, carboplatin, melphalan, and vincristine sulfate. These medications are used in different combinations and methods to treat the disease. The purpose of the study is to evaluate the effectiveness of these treatments in preserving the eye without the need for external beam radiation.

The study is divided into three parts. In the first part, patients with certain types of retinoblastoma receive intravenous chemotherapy with etoposide and carboplatin, followed by a treatment that combines chemotherapy and heat therapy, known as chemothermotherapy. The second part involves patients with more advanced retinoblastoma receiving melphalan through a method called intra-arterial chemotherapy, where the drug is delivered directly to the eye’s blood supply. The third part of the study includes patients with more severe cases, who receive a combination of three drugs, including vincristine sulfate, along with local treatments like laser therapy and cryotherapy, which uses extreme cold to destroy cancer cells.

The study aims to determine how well these treatments work in saving the eye and preventing the need for radiation therapy. It also looks at the side effects of the treatments and the risk of the cancer coming back. The study will follow patients over time to monitor their response to the treatments and any potential long-term effects. The ultimate goal is to find effective ways to treat retinoblastoma while preserving the patient’s vision and quality of life.

1 initial treatment phase

The treatment begins with the administration of intravenous chemotherapy. This involves the use of two medications: etoposide and carboplatin. These medications are given through a vein, which is known as intravenous use.

The purpose of this phase is to start treating the retinoblastoma and to evaluate the effectiveness of the treatment in preserving the eye without the need for external radiation.

2 chemothermotherapy phase

Following the initial chemotherapy, a treatment called chemothermotherapy is administered. This phase does not include laser treatment on day 8.

The goal is to continue treating the retinoblastoma while reducing the number of laser sessions needed.

3 intra-arterial chemotherapy phase

For certain patients, melphalan is administered directly into the artery that supplies the eye. This is known as intra-arterial chemotherapy.

This method is used to treat specific cases of retinoblastoma and is combined with local treatments such as laser treatment, cryoapplication, or radioactive plaques.

4 local treatment phase

Local treatments may include laser treatment, cryoapplication, or the use of radioactive plaques. These treatments are aimed at preserving the eye and are used in combination with chemotherapy.

In some cases, melphalan is injected directly into the eye, known as intravitreal use, to further treat the retinoblastoma.

5 follow-up phase

Regular follow-up appointments are scheduled to monitor the response to treatment and to check for any signs of relapse.

These follow-ups include eye examinations, which may be performed under general anesthesia for younger children, and assessments of any side effects from the treatments.

Who Can Join the Study?

  • Patients must not have been previously treated with chemotherapy or radiotherapy for this tumor or any other cancer.
  • Patients must be able to have long-term follow-up care.
  • Parents or legal representatives must provide written informed consent for the child to participate.
  • Patients must have social security coverage.
  • There should be no medical reasons preventing the use of the study treatments.
  • For Study 1 and Study 3, children must be between 0 to 6 years old.
  • For Study 1, patients with unilateral retinoblastoma in groups A, B, or C, or bilateral retinoblastoma in groups A, B, or C, are eligible. This excludes patients with a threat to the macula (the central part of the retina) and those with both eyes in group D or only one remaining eye.
  • For Study 1, patients less than six months old with unilateral retinoblastoma in groups B, C, or D, or bilateral retinoblastoma with one eye in group D and the other eye treatable without chemotherapy, are eligible.
  • For Study 2, patients with bilateral retinoblastoma that is very different in each eye, with one eye in group D treatable with intra-arterial chemotherapy using Melphalan, and the other eye treatable with local treatments without chemotherapy, are eligible.
  • For Study 2, children must be between 6 months to 6 years old.
  • For Study 2, patients with unilateral or bilateral retinoblastoma in group B, C, or D are eligible.
  • For Study 3, children with bilateral retinoblastoma in group D or with only one eye that can be treated conservatively are eligible.

Who Cannot Join the Study?

  • Patients with bilateral group D retinoblastoma, which means the cancer is in both eyes and is more advanced.
  • Patients with bilateral macular threat, meaning the cancer is threatening the central part of the retina in both eyes.
  • Patients who are not suitable for local treatment in one eye, which means treatments like laser or cryotherapy cannot be used effectively.
  • Patients who are part of a vulnerable population, which refers to groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Fondation A De Rothschild Paris France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Universitaire De Caen Normandie Caen France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
20.02.2012

Trial locations

VP16 is a medication used in the trial as part of the intravenous chemotherapy regimen. It is used to help treat retinoblastoma by targeting and killing cancer cells, which can help preserve the eye without the need for external beam radiation.

Carboplatin is another medication used in the intravenous chemotherapy regimen. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. This helps in treating retinoblastoma and aims to preserve the eye.

Melphalan is administered intra-arterially in the trial. It is delivered directly to the ophthalmic artery to target the cancer cells in the eye more effectively. This method helps in treating retinoblastoma while minimizing the need for external radiation.

Laser Treatment is a local therapy used in combination with chemotherapy. It involves using a focused beam of light to destroy cancer cells in the eye, helping to preserve vision and avoid more invasive treatments.

Cryoapplication is a local treatment that involves freezing cancer cells to kill them. It is used alongside chemotherapy to enhance the treatment’s effectiveness in preserving the eye.

I125 Radioactive Plaques are small devices placed on the eye to deliver targeted radiation to the tumor. This local treatment is used in combination with chemotherapy to help control the cancer while preserving the eye.

Intravitreal Melphalan is a method of delivering melphalan directly into the eye. This approach targets the cancer cells more precisely and is used in conjunction with other treatments to preserve the eye without external radiation.

Retinoblastoma – Retinoblastoma is a rare type of eye cancer that typically develops in early childhood, usually before the age of five. It originates in the retina, the light-sensitive lining at the back of the eye. The disease can affect one or both eyes and may cause symptoms such as a white color in the pupil, eye redness, or vision problems. As the cancer progresses, it can lead to further complications, including the potential spread to other parts of the body. The progression of retinoblastoma can vary, with some cases remaining localized to the eye while others may become more aggressive. Early detection and intervention are crucial in managing the disease and preserving vision.

Trial ID:
2024-517275-21-00
Protocol code:
IC 2011-05
NCT ID:
NCT02866136
Trial Phase:
Therapeutic exploratory (Phase II)

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