Trial record 19 of 50 for:    eye diseases AND university of iowa | Exclude Unknown

Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00335738
First received: June 8, 2006
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they work compared to observation only in treating patients who have undergone surgery for newly diagnosed retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, no additional treatment is needed for the tumor until it progresses. In this case, observation may be sufficient.


Condition Intervention Phase
Intraocular Retinoblastoma
Drug: liposomal vincristine sulfate
Drug: carboplatin
Drug: etoposide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival (EFS) [ Time Frame: At 2 years ] [ Designated as safety issue: No ]
    EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features (treated with adjuvant chemotherapy) and separately for subjects without high risk features (treated with enucleation alone).

  • Overall survival (OS) [ Time Frame: At 2 years ] [ Designated as safety issue: No ]
    OS distributions will be estimated by the Kaplan-Meier method for patients with high risk features (treated with adjuvant chemotherapy) and separately for subjects without high risk features (treated with enucleation alone). Survival data will be formally reviewed separately for subjects with and without high risk features for which adjuvant therapy is indicated, using the Lan-DeMets implementation of group sequential boundaries.


Secondary Outcome Measures:
  • Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    Toxicities associated with the adjuvant therapy for patients with high risk features will be descriptively summarized. The prevalence of well-defined, histopathologic features of interest will be summarized with descriptive statistics and 95% confidence intervals for proportions.


Enrollment: 331
Study Start Date: December 2005
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (chemotherapy)
Patients receive liposomal vincristine sulfate IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: liposomal vincristine sulfate
Given IV
Other Names:
  • liposomal vincristine
  • Marqibo
  • vincristine liposomal
  • vincristine sulfate liposome injection
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
No Intervention: Group 2 (no intervention)
Patients undergo observation periodically for at least 5 years.

Detailed Description:

OBJECTIVES:

I. Prospectively determine the prevalence of high-risk histopathologic features, such as choroidal involvement, optic nerve invasion, and scleral and anterior segment involvement, in patients with newly diagnosed unilateral retinoblastoma who have undergone enucleation.

II. Demonstrate that patients without certain high-risk features can be successfully treated with enucleation alone by estimating the event-free survival (EFS) (where an event is defined as the occurrence of extraocular or metastatic disease) and overall survival (OS).

III. Estimate the EFS and OS of patients with specific high-risk features who are uniformly treated with adjuvant chemotherapy comprising vincristine, carboplatin, and etoposide.

IV. Estimate the incidence of toxicities associated with the proposed adjuvant chemotherapy regimen.

OUTLINE: This is a prospective, nonrandomized, multicenter study. Patients are assigned to 1 of 2 groups according to presence of high-risk histopathologic features.

GROUP 1 (high-risk features): Patients receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

GROUP 2 (no high-risk features): Patients undergo observation periodically for at least 5 years.

After completion of study treatment, patients in group 1 are followed periodically for at least 5 years.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed unilateral retinoblastoma
  • Underwent enucleation as primary therapy within the past 5 weeks

    • Must enroll and submit pathology slides within 21 days of enucleation
    • Adjuvant chemotherapy must begin within 35 days after enucleation
  • Disease with or without high-risk histopathologic features

    • High-risk features are defined as any of the following:

      • Posterior uveal invasion (includes choroidal invasion)
      • Any degree of concomitant choroid and/or optic nerve involvement
      • Tumor involving the optic nerve posterior to the lamina cribrosa as an independent finding
      • Scleral invasion
      • Anterior chamber seeding
      • Ciliary body infiltration
      • Iris infiltration
  • No evidence of extraocular retinoblastoma clinically, by CT scan, or by MRI of the brain and orbits with and without gadolinium
  • No tumor at the cut end of the optic nerve on any eye enucleated as evidenced by histologic examination prior to study entry
  • No systemic metastases as evidenced by bone marrow scan, bone scan, or any other additional test at study entry
  • Lansky performance status 50-100%
  • Hemoglobin > 8 g/dL
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine adjusted according to age as follows:

    • No greater than 0.4 mg/dL (≤ 5 months)
    • No greater than 0.5 mg/dL (6 months -11 months)
    • No greater than 0.6 mg/dL (1 year-23 months)
    • No greater than 0.8 mg/dL (2 years-5 years)
    • No greater than 1.0 mg/dL (6 years-9 years)
    • No greater than 1.2 mg/dL (10 years-12 years)
    • No greater than 1.4 mg/dL (13 years and over [female])
    • No greater than 1.5 mg/dL (13 years to 15 years [male])
    • No greater than 1.7 mg/dL (16 years and over [male])
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • AST or ALT < 2.5 times ULN for age
  • No prior therapy other than enucleation
  • No prior chemotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335738

  Show 56 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Murali Chintagumpala Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00335738     History of Changes
Other Study ID Numbers: ARET0332, NCI-2009-00423, CDR0000483043, U10CA098543, COG-ARET0332
Study First Received: June 8, 2006
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eye Neoplasms
Eye Diseases
Retinal Diseases
Retinoblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Neoplasms by Site
Etoposide phosphate
Carboplatin
Etoposide
Vincristine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on October 02, 2014