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)
| City: |
|
Cincinnati |
| State: |
|
Ohio |
| Zip Code: |
|
45229 |
| Conditions: |
|
Retinoblastoma |
| Purpose: |
|
The investigators are testing subtenon carboplatin in combination with vincristine and
topotecan given by vein in the hopes of finding a drug combination that may be effective
against retinoblastoma that has come back (recurrent) or is resistant to other treatment
(refractory).
The goals of this study are:
- To decide if the drug combination is a useful treatment for recurrent or refractory
retinoblastoma
- To test the safety of the drug combination and to see what kind of effects (good and
bad) can be expected from the drug combination
- To measure visual changes before and after the study therapy
- To use a special MRI scan to measure brain function involved in vision processing, both
before and after the study therapy
In this study, the investigators are also testing a new experimental way of giving
carboplatin "subtenon carboplatin". The carboplatin will be given directly in the eye
through a needle placed under the covering of the eye. This is to try to get more
carboplatin to the retinoblastoma inside the eye.
|
| Study Summary: |
|
|
| Criteria: |
|
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
|
| NCT ID: |
|
NCT00980551 |
| Primary Contact: |
|
Principal Investigator
James Geller, MD
Children's Hospital Medical Center, Cincinnati
James Geller, MD
Phone: (513) 636-6312
Email: James.Geller@cchmc.org
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Cincinnati, Ohio 45229
United States
James Geller, MD
Phone: 513-636-6312
Email: James.Geller@cchmc.org
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 17, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|