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A Pilot Study of Intravenous Topotecan and Vincristine in Combination With Subconjunctival Carboplatin for Patients With a History of Bilateral Retinoblastoma and Refractory/Recurrent Intraocular Disease (IND# 104,942)


N/A
N/A
10 Years
Open (Enrolling)
Both
Retinoblastoma

Thank you

Trial Information

A Pilot Study of Intravenous Topotecan and Vincristine in Combination With Subconjunctival Carboplatin for Patients With a History of Bilateral Retinoblastoma and Refractory/Recurrent Intraocular Disease (IND# 104,942)


Inclusion Criteria:



- Age: ≤ 10 years of age

- Diagnosis: Patients must have a history of bilateral Retinoblastoma AND
Recurrent/Refractory Intra-Ocular Retinoblastoma considered not amenable to cure with
local therapies alone (photocoagulation with argon laser, cryotherapy, transpupillary
thermotherapy, radioactive plaque therapy).

- Therapeutic Options: Patient's disease status is one for which there are no known
options proven to provide a high chance for ocular salvage or cure other than
external beam radiation or enucleation.

- Remaining visual function in target eye (s) is required

- Life Expectancy of > 8 weeks

- Lansky ≥ 50

- Prior Therapy: Patients must have local relapsed/refractory disease after receiving
standard upfront therapy involving at least one chemotherapeutic regimen. There is no
limit to prior chemotherapeutic regimens permitted. Patients may have received
previous intravenous carboplatin, but may not have received prior subtenon
carboplatin or intravenous topotecan.

- Patients must have recovered from the acute toxic effects of all prior chemotherapy,
immunotherapy, or radiotherapy prior to entering this study, as described below:

- Myelosuppressive chemotherapy: patients must not have received myelosuppressive
chemotherapy within 3 weeks of study enrollment

- Biologic therapies: Patients must not have received biologic anti-cancer agents
within one week of study enrollment

- Radiation therapy: Four weeks must have elapsed since external beam radiation
therapy, if given.

- Adequate Bone Marrow Function Defined as:

- Peripheral absolute neutrophil count (ANC) ≥ 750/µL

- Platelet count ≥ 75,000/µL (transfusion independent, defined as not receiving
platelet transfusions within a 7-day period prior to enrollment)

- Hemoglobin ≥ 8.0 gm/dL (may receive RBC transfusions)

- Adequate Renal Function Defined as:

- Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR threshold
creatinine values based on age/gender derived from the Schwartz formula for
estimating GFR

- Adequate Liver Function Defined As:

- Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN)
for age

- SGPT (ALT) ≤ 5 x upper limit of normal (ULN) for age

- Serum albumin ≥ 2 g/dL

Exclusion Criteria:

- Extra-ocular retinoblastoma

- Asynchronous involvement of the contralateral eye, previously untreated

- Uncontrolled infection at time of protocol entry

- Concomitant Medications:

- Growth factors that support platelet or white cell number or function must not
have been administered within the past 3 days

- Patients who are currently receiving investigational drugs, or who have received
an investigational drug within the last 7 days, are ineligible

- Patients who are currently receiving other anti-cancer agents are ineligible

- Patients who in the opinion of the investigator may not be able to comply with the
safety monitoring requirements of the study are not eligible

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the event-free survival, where an event is defined at the ocular level as the need for non-protocol therapy defined as additional non-protocol chemotherapy, external beam radiation, or enucleation.

Outcome Time Frame:

at 1 year

Safety Issue:

No

Principal Investigator

James Geller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital Medical Center, Cincinnati

Authority:

United States: Food and Drug Administration

Study ID:

RELRB1

NCT ID:

NCT00980551

Start Date:

March 2010

Completion Date:

March 2015

Related Keywords:

  • Retinoblastoma
  • Retinoblastoma

Name

Location

Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039