Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004006
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Radiation Therapy and Bone Marrow Transplantation in Treating Patients With Retinoblastoma
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Treatment for Extrachoroidal or Metastatic Retinoblastoma
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed by bone marrow transplantation in treating patients who have retinoblastoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed by bone marrow transplantation in treating patients who have retinoblastoma
Detailed Description:
OBJECTIVES
Evaluate the feasibility of sequential therapy with carboplatin etoposide cyclophosphamide doxorubicin topotecan and radiotherapy followed by autologous bone marrow transplantation in patients with extrachoroidal or metastatic retinoblastoma
Assess this treatment regimen in terms of response and toxicity before and after autologous bone marrow transplantation in this patient population
OUTLINE Patients receive carboplatin IV on day 1 and etoposide IV over 1 hour daily on days 1-3 of weeks 0 6 and 12 plus cyclophosphamide IV or orally daily on days 1-7 doxorubicin IV on day 8 and carboplatin IV over 1 hour on day 10 on weeks 3 9 and 15 Beginning on week 6 patients receive concurrent radiotherapy 5 days a week over 4-6 weeks Patients with meningeal involvement receive topotecan intrathecally twice weekly for 3 weeks and then weekly for 3 weeks before starting radiotherapy Beginning one day after each treatment course patients receive filgrastim G-CSF subcutaneously daily for 10 days
Patients undergo bone marrow collection before or after week 6 Following hematologic recovery patients receive several days of high dose chemotherapy consisting of cyclophosphamide and topotecan followed by bone marrow reinfusion
Patients are followed at 6 9 and 12 months and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Evaluate the feasibility of sequential therapy with carboplatin etoposide cyclophosphamide doxorubicin topotecan and radiotherapy followed by autologous bone marrow transplantation in patients with extrachoroidal or metastatic retinoblastoma
Assess this treatment regimen in terms of response and toxicity before and after autologous bone marrow transplantation in this patient population
OUTLINE Patients receive carboplatin IV on day 1 and etoposide IV over 1 hour daily on days 1-3 of weeks 0 6 and 12 plus cyclophosphamide IV or orally daily on days 1-7 doxorubicin IV on day 8 and carboplatin IV over 1 hour on day 10 on weeks 3 9 and 15 Beginning on week 6 patients receive concurrent radiotherapy 5 days a week over 4-6 weeks Patients with meningeal involvement receive topotecan intrathecally twice weekly for 3 weeks and then weekly for 3 weeks before starting radiotherapy Beginning one day after each treatment course patients receive filgrastim G-CSF subcutaneously daily for 10 days
Patients undergo bone marrow collection before or after week 6 Following hematologic recovery patients receive several days of high dose chemotherapy consisting of cyclophosphamide and topotecan followed by bone marrow reinfusion
Patients are followed at 6 9 and 12 months and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G99-1555 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA021765 |
| P30CA021765 | NIH | None | None |
| SJCRH RET4 | None | None | None |