Trial record 14 of 27 for:    Open Studies | "Retinoblastoma"

Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma (RELRB1)

This study is currently recruiting participants.
Verified December 2010 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00980551
First received: September 18, 2009
Last updated: December 10, 2010
Last verified: December 2010
  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.


Condition Intervention
Retinoblastoma
Drug: subtenon Carboplatin
Drug: Topotecan Hydrochloride
Drug: Vincristine
Drug: Filgrastim

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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. [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • To estimate the patterns of response, and response rate of locally refractory retinoblastoma to combination intravenous and peri-ocular chemotherapy. [ Time Frame: at 1 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the toxicities associated with the proposed regimen. [ Time Frame: at 1 yr ] [ Designated as safety issue: Yes ]
  • To describe the histologic findings in the eyes ultimately requiring enucleation. [ Time Frame: at 1 yr ] [ Designated as safety issue: No ]
  • To describe the visual acuity of patients with advanced intraocular retinoblastoma before and after the proposed therapy. [ Time Frame: at 1 yr ] [ Designated as safety issue: No ]
  • To describe primary visual cortex function in patients with retinoblastoma via functional Magnetic Resonance Imaging (fMRI) technique both before and after the proposed therapy. [ Time Frame: at 1 yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topotecan/Vincristine with subtenon Carboplatin Drug: subtenon Carboplatin
Available in 50mg, 150mg, 450 mg, 600mg vials. It is provided as a premixed aqueous solution or lyophilized powder for injection given on day 1/week 10 (cycles 1-3).
Other Name: Paraplatin
Drug: Topotecan Hydrochloride
Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base. Given intravenously on days 1-5 of each week (cycles 1-6).
Other Name: Hycamtin
Drug: Vincristine
Each vial contains vincristine sulfate, 1 mg; mannitol, 100 mg; sterile water for injection; Acetic acid and sodium acetate are added for pH control. Given intravenously on day 1/week 1 (cycles 1-6).
Other Name: Oncovin
Drug: Filgrastim
Supplied as a clear solution in 300 mcg/ml 1 ml or 1.6 ml vials and prefilled syringes containing 300mcg/0.5mL or 480mcg/0.8mL. Given intravenously on day 6 of each week (cycles 1-6).
Other Name: Neupogen

  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980551

Contacts
Contact: James Geller, MD (513) 636-6312 James.Geller@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: James Geller, MD    513-636-6312    James.Geller@cchmc.org   
Principal Investigator: James Geller, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: James Geller, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: James Geller, MD, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT00980551     History of Changes
Other Study ID Numbers: RELRB1
Study First Received: September 18, 2009
Last Updated: December 10, 2010
Health Authority: United States: Food and Drug Administration

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
Vincristine
Carboplatin
Topotecan
Lenograstim
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on April 23, 2014