Alternating Systemic Chemotherapy and Intra-Arterial Melphalan (IAM) Chemotherapy in Children With Intra-Ocular Retinoblastoma

Stopped early · Phase 1

Conditions studied: Advanced Intra-Ocular Retinoblastoma, Retinoblastoma

In brief

The purpose of this study is to test the safety of the treatment combination of alternating standard chemotherapy and another (melphalan) chemotherapy at different interval schedules. Researchers want to find out what effects, good and/or bad, the treatment combination has on the patients and their retinoblastoma.

Key facts

Study ID: NCT02116959
Run by: University of California, San Francisco
People needed: 6
Starts: 2014-07-23
Expected to finish: 2019-05-25
Last updated by the study team: 2020-04-16

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age greater than or equal to 3 months up to 18 years.
Intraocular retinoblastoma not previously treated with systemic chemotherapy, radiation therapy, or IA therapy. Local retinal therapy such as laser photocoagulation and cryotherapy will be permitted.
Unilateral or bilateral retinoblastoma (RB) patients are eligible
Patients will be registered on study based on the local exam under anesthesia (EUA) done for diagnostic purposes prior to study entry. The EUA done at study entry should be done within 14 days prior to study entry
Patients may have had enucleation of one eye, as long as the remaining eye meets the eligibility criteria
Involved eye(s) must meet the definition for International Classification of Retinoblastoma
For unilateral retinoblastoma (see Appendix 1 for International Classification of Retinoblastoma):
Group A eye that has failed local therapy
Group B eye that has failed local therapy
Group C eye that has failed local therapy
Group D eye
Group E eye that is not buphthalmic, is not planned for enucleation after first cycle of chemotherapy, and is in a child less than 1 year of age
For bilateral retinoblastoma (see Appendix 1 for International Classification of Retinoblastoma):
Group A and Group A eyes that have failed local therapy
Group A and Group B eyes that have failed local therapy
Group A and Group C eyes
Group A and Group D eyes
Group A and Group E eyes in which the Group E eye is not planned for enucleation after first cycle of chemotherapy
Group B and Group B eyes that have failed local therapy
Group B and Group C eyes
Group B and Group D eyes
Group B and Group E eyes in which the Group E eye is not planned for enucleation after first cycle of chemotherapy
Group C and Group C eyes
Group C and Group D eyes
Group C and Group E eyes even if early enucleation is planned for the Group E eye.

You may not qualify if…

Any evidence of extraocular retinoblastoma clinically or by magnetic resonance imaging (MRI) of brain and orbits with and without gadolinium. MRI may be done within 21 days prior to study entry.
Evidence of systemic metastases on bilateral bone marrow, lumbar puncture, bone scan (or Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) scan), and/or any other additional tests done at study entry.
Patients who have previously been treated with chemotherapy (with the exception of second inclusion criteria) radiation therapy, or intra-arterial therapy.
Eyes with tumors that are amenable to local therapy with laser or cryotherapy without threat to vision
Any technical factor that would prohibit use of catheterization of the ophthalmic artery (e.g., small for age infant, untreatable allergy to contrast).
Abnormal cerebral vasculature noted on MR angiography that would increase the risk of the procedure, including but not limited to an incomplete Circle of Willis. Other abnormalities that are less severe than an incomplete Circle of Willis will be reviewed by the study chair in consultation with a neuro-interventional radiologist.
Any serious ongoing condition, such as an untreated infection or organ dysfunction.
Patients receiving any medications or substances that are inhibitors or inducers of CYP450 enzyme(s) are ineligible.
Pregnant women are excluded from this study due to potential for teratogenic or abortifacient effects of therapy. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother breastfeeding should be discontinued upon start of protocol therapy.

Where it is running

University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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