Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma
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Purpose
The purpose of this study is to show that chemotherapy delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment alternative to conventional systemic chemotherapy, external beam radiation, and surgical removal of the eye.
| Condition | Intervention | Phase |
|---|---|---|
|
Retinoblastoma |
Drug: Melphalan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma |
- Number of patients who complete therapy without the need for additional treatment including systemic chemotherapy, external beam radiation, or enucleation. [ Time Frame: Within the first six months after the initial treatment. ] [ Designated as safety issue: No ]The primary objective of this study is to show that intra-arterial delivery of the chemotherapeutic agent is successful in treating intraocular retinoblastoma, defined as avoiding systemic chemotherapy, external beam radiation, and enucleation.
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | August 2021 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
-
Drug: Melphalan hydrochloride
Drug administered intra-arterially (injection in the artery).
Standard dose:
2.5mg (3-6 month old) 3.0 mg (6-12 month old) 4.0 mg (1-3 year old) 5.0 mg (>3 years old)
Dose modification: decrease standard dose by 25% if there are signs of toxicity. Increase the dose by 25% if there is inadequate tumor response.
Frequency: 2 treatment cycles at 3-4 week intervals, with a third treatment cycle administered if the tumor requires it.
Dose not to exceed 0.5mg/kg, per treatment cycle.
Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. Administration of the drug directly to the targeted site thus avoids the complications and adverse events associated with toxicity from systemic, rather than local, chemotherapy.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients newborn to 18 years old.
- Patients with intraocular retinoblastoma, unilateral or bilateral, who would be treated either by systemic chemotherapy, EBR, or enucleation would be considered for this study.
Exclusion Criteria:
- Patients over the age of 18.
- Patients with small, localized intraocular Rb amenable to focal therapy (laser or cryotherapy).
- Patients with extraocular disease evident on MRI (extension into the optic nerve), massive choroidal/uveal invasion (grade IIC or IID per ARET0332) or disease outside the globe evident on MRI or physical examination.
- Documented hypercoagulable disorders or vasculopathies.
- Laboratory exclusion criteria: GFR < 60 mL/min/1.73 m2
Contacts and Locations| Contact: Monica Pearl, M.D. | 410-955-8525 | msmit135@jhmi.edu |
| Contact: Amber Jones, B.A., CCRP | 410-502-0736 | ajones78@jhmi.edu |
| United States, Maryland | |
| The Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Sub-Investigator: James Handa, M.D. | |
| Sub-Investigator: Alan Friedman, M.D. | |
| Sub-Investigator: Philippe Gailloud, M.D. | |
| Principal Investigator: | Monica Pearl, M.D. | The Johns Hopkins Hospital |
More Information
Publications:
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01293539 History of Changes |
| Other Study ID Numbers: | J1071, NA_00040637 |
| Study First Received: | January 21, 2011 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
Retinoblastoma intra-arterial chemotherapy angiography |
Additional relevant MeSH terms:
|
Retinoblastoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Retinal Neoplasms Eye Neoplasms Neoplasms by Site Eye Diseases |
Retinal Diseases Melphalan Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013