RetinoblastomaPhase 2NCT00002794
Carboplatin Plus Vincristine in Treating Children With Retinoblastoma
A Phase 2 study testing carboplatin and vincristine sulfate in people with Retinoblastoma, run by St. Jude Children's Research Hospital at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- carboplatin and vincristine sulfate
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 1996to Jun 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS: Newly diagnosed retinoblastoma Bilateral or multifocal unilateral disease in children under age 10 Unilateral, multifocal tumors less than 5 dd in children under age 2 No metastatic disease Disease evidenced by ophthalmoscopic/imaging exam, ultrasound, CT, or MRI Fundus drawings and photographs required
PATIENT CHARACTERISTICS: Age: 10 and under Performance status: Not specified Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
About this study
Official title: Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma.
Read the detailed description
OBJECTIVES: I. Estimate the objective response rate in infants and children with retinoblastoma when treated with carboplatin (CBDCA) and vincristine (VCR) every 3 weeks for 24 weeks. II. Assess the success of this regimen in delaying radiotherapy and eliminating the need for surgery by estimating the cumulative incidence function of treatment failure. III. Estimate the cumulative incidence of failure of this regimen as measured by subsequent treatment with radiotherapy or surgery.
OUTLINE: All patients receive carboplatin and vincristine every 3 weeks for a maximum of 8 courses. Patients with disease progression after at least 2 courses are removed from study and considered for alternative therapy. Patients are followed every 6 weeks for 1 year, every 2 months for 1 year, every 3-4 months for 3 years, and yearly for 12 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 4.5 years.
- Conditions
- Retinoblastoma
- Being tested
- carboplatin, vincristine sulfate
- Keywords
- intraocular retinoblastoma
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2004 (estimated)
- Study startFeb 1996
- Primary completionJun 2001
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Carlos Rodriguez-Galindo, MD, Study chair, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002794
- Sponsor's protocol ID
- CDR0000064874
- Other IDs
- P30CA021765, P01CA023099, SJCRH: RET3, NCI-H96-0935
- Status last verified
- Oct 2011
- First submitted
- 1 Nov 1999
- Last updated
- 4 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma
- ClinicalTrials.gov ID
- NCT00002794
- Acronym / sponsor ID
- CDR0000064874
- Conditions
- Retinoblastoma
- Keywords
- intraocular retinoblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1996
- Primary completion
- Jun 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 26 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma.
Detailed description
OBJECTIVES: I. Estimate the objective response rate in infants and children with retinoblastoma when treated with carboplatin (CBDCA) and vincristine (VCR) every 3 weeks for 24 weeks. II. Assess the success of this regimen in delaying radiotherapy and eliminating the need for surgery by estimating the cumulative incidence function of treatment failure. III. Estimate the cumulative incidence of failure of this regimen as measured by subsequent treatment with radiotherapy or surgery.
OUTLINE: All patients receive carboplatin and vincristine every 3 weeks for a maximum of 8 courses. Patients with disease progression after at least 2 courses are removed from study and considered for alternative therapy. Patients are followed every 6 weeks for 1 year, every 2 months for 1 year, every 3-4 months for 3 years, and yearly for 12 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 4.5 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| vincristine sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Rodriguez-Galindo, MD study chair
St. Jude Children's Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin and vincristine sulfate in people with Retinoblastoma, run by St. Jude Children's Research Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2011.