Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003141|
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : March 28, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumors Central Nervous System Tumors Neuroblastoma Sarcoma||Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: thiotepa Drug: vincristine sulfate Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation||Phase 1|
- Determine the maximum tolerated dose of thiotepa in infants with malignant brain or spinal cord tumors receiving intensive chemotherapy.
- Determine the feasibility and toxicity of intensive chemotherapy with peripheral blood stem cell (PBSC) rescue in these patients.
- Assess the feasibility of harvesting PBSCs in these patients.
- Determine the complete response rate and overall event-free survival rate in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
Patients undergo surgery for diagnosis and maximal tumor resection.
Within 6 weeks of surgery or when stable, patients begin induction chemotherapy comprising cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; cyclophosphamide IV over 1 hour on days 1-2; and etoposide IV over 1 hour on days 0-2. Twenty four hours after the last cyclophosphamide dose, patients receive filgrastim (G-CSF) subcutaneously (SC) and undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Within 6 weeks after induction chemotherapy, patients receive consolidation chemotherapy comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses of thiotepa IV over 2 hours. Patients then undergo peripheral blood stem cell transplantation 48 hours after the last thiotepa dose. Patients receive G-CSF SC daily on days 3 to 21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients experiencing dose-limiting toxicity due to thiotepa are removed from the study.
Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 3 years, and then annually for 3 years or until relapse.
PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors|
|Study Start Date :||March 1998|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||October 2011|
Experimental: Treatment (combination chemotherapy, PBSC transplant)
Pts undergo conventional surgery for diagnosis & max tumor resection. In 6 wks of surgery or when stable pts begin induction chemotherapy(cisplatin IV over 6 hrs on day 0; vincristine sulfate IV on days 0,7,14; cyclophosphamide IV over 1 hr on days 1-2; and etoposide IV over 1 hr on days 0-2. 24 hrs after the last cyclophosphamide dose, pts receive filgrastim (G-CSF) & undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 crs. Within 6 wks after induction, pts receive consolidation (carboplatin IV over 2 hrs on days 0-1 next esc. doses of thiotepa IV over 2 hrs. Pts undergo peripheral blood stem cell transplantation 48 hrs after last thiotepa dose. Pts receive G-CSF SC daily on days 3-21. Treatment repeats every 21 days for up to 3 crs. Pts with dose-limiting toxicity due to thiotepa are removed from study. Pts are followed at 4 wks, 3 mths for 1 yr, 6 mths for 3 yrs, annually for 3 yrs or until relapse.
Other Names:Drug: carboplatin
Other Names:Drug: cisplatin
Other Names:Drug: cyclophosphamide
Other Names:Drug: etoposide
Other Names:Drug: thiotepa
Other Names:Drug: vincristine sulfate
Other Names:Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation
- Feasibility [ Time Frame: Up to 4 weeks after completion of study treatment ]Demonstrate the feasibility of administering this regimen, to select an acceptable Thiotepa dose for Consolidation therapy, and to document significant toxicities and estimate their overall rates
- Maximal tolerated dose of thiotepa for consolidation therapy [ Time Frame: 9 weeks ]The dose level will be assigned within 3 working days prior to beginning Consolidation.
- Overall rates of significant toxicities including grade IV ototoxicity, electrolytic wasting (grade IV), and hemorrhagic cystitis (grade IV) [ Time Frame: Up to 6 years ]Estimates will be obtained using life-table methods with an event defined as the first occurrence of toxicity. Graded using the CCG Toxicity and Complications Criteria.
- Event Free Survival [ Time Frame: From the time of study entry to the first occurrence of death by any cause, progression or recurrence of disease or occurrence of a second malignant neoplasm, assessed up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003141
Show 71 Study Locations
|Study Chair:||Bruce H. Cohen, MD||The Cleveland Clinic|