Trials / Completed
CompletedNCT00002515
Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer
Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa, carboplatin, and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer.
Detailed description
OBJECTIVES: * Improve the long term disease-free survival of patients with rare cancers at high risk for lethal relapse by using myeloablative chemotherapy with thiotepa, carboplatin, and topotecan followed by autologous bone marrow or peripheral blood stem cell rescue. OUTLINE: Autologous bone marrow or peripheral blood stem cells (PBSC) are harvested. Patients receive high-dose thiotepa IV over 3 hours on days -8 to -6, carboplatin IV over 4 hours on days -5 to -3, and topotecan IV over 30 minutes on days -8 to -4. Autologous bone marrow or PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) IV twice daily beginning on day 1. Patients are followed for 1 year. PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.
Conditions
- Childhood Germ Cell Tumor
- Extragonadal Germ Cell Tumor
- Head and Neck Cancer
- Kidney Cancer
- Liver Cancer
- Lymphoma
- Neuroblastoma
- Ovarian Cancer
- Retinoblastoma
- Sarcoma
- Testicular Germ Cell Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | filgrastim | |
| DRUG | carboplatin | |
| DRUG | thiotepa | |
| DRUG | topotecan hydrochloride | |
| PROCEDURE | autologous bone marrow transplantation | |
| PROCEDURE | bone marrow ablation with stem cell support | |
| PROCEDURE | in vitro-treated bone marrow transplantation |
Timeline
- Start date
- 1992-10-01
- Primary completion
- 2005-04-01
- Completion
- 2005-04-01
- First posted
- 2003-01-27
- Last updated
- 2013-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00002515. Inclusion in this directory is not an endorsement.