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Eligibility
for people ages 4 months and up
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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.

Official Title

A Pilot Study Evaluating the Safety of Alternating Systemic Chemotherapy and Intra-Arterial Melphalan Chemotherapy in Children With Newly Diagnosed Advanced Intra-Ocular Retinoblastoma

Keywords

Advanced Intra-Ocular Retinoblastoma Retinoblastoma Systemic Chemotherapy Melphalan Carboplatin Etoposide Vincristine

Eligibility

You can join if…

Open to people ages 4 months and up

  • Age greater than or equal to 4 months.

    1. Age greater than or equal to 4 months but less than 6 months of age can receive up to 2 cycles of systemic chemotherapy to bridge until 6 months (cohort 2).
    2. Age greater than or equal to 6 months at study entry (cohort 1) to receive alternating therapy.
  • 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 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 Group D or E

    1. Group D eye can be unilateral or bilateral
    2. Group E eye will be eligible if bilateral involvement or unilateral involvement in a child less than 1 year of age
    3. Patients with bilateral disease in which one of the eyes has Group C disease are not eligible until interval level 2 in cohort 1 and are not eligible for cohort 2
  • Adequate Renal Function defined as: creatinine clearance or radioisotope GFR ³70mL/min/1.73 m2 OR a serum creatinine based on age and gender as follows:

    The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC

  • Adequate hematological function defined as:

    1. Absolute Neutrophil Count> 750/microliter
    2. Platelet Count> 100,000/microliter
  • Adequate liver function defined as total bilirubin should be less than or equal to 1.5 x upper limit of normal (ULN) for age and SGOT (AST) and SGPT (ALT) < 5 x upper limit of normal (ULN) for age
  • Adequate coagulation system as defined as an international normalized ratio (INR) of less than 1.4 and a partial thromboplastin time (PTT) of less than 34
  • The effects of melphalan, carboplatin, etoposide and vincristine are harmful on the developing human fetus. For this reason, women of child-bearing potential and men must agree to use adequate contraception: hormonal or barrier method of birth control; abstinence, prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

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Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02116959
Lead Scientist
Anuradha Banerjee
Study Type
Interventional
Last Updated
July 18, 2016
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