High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer
- Conditions
- Cancer
- Interventions
- Biological: filgrastimProcedure: peripheral blood stem cell transplantation
- Registration Number
- NCT00002854
- Lead Sponsor
- City of Hope Medical Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor 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 patients who have advanced cancer.
- Detailed Description
OBJECTIVES:
* Evaluate the feasibility of administering 2 courses of high dose chemotherapy consisting of etoposide, cisplatin, and cyclophosphamide followed by ifosfamide, carboplatin, and paclitaxel (IC-T), each administered with filgrastim (G-CSF) and autologous stem cell support, to patients with advanced carcinomas.
* Describe the toxicity of these high dose chemotherapy regimens.
* Define the maximum tolerated dose of paclitaxel deliverable in this high dose regimen.
* Describe the pharmacokinetics of escalating doses of paclitaxel given as a 24-hour continuous infusion.
* Determine the disposition of carboplatin administered in the IC-T regimen.
OUTLINE: At least 4 weeks prior to chemotherapy, patients undergo stem cell collection following filgrastim (G-CSF) mobilization. Sufficient stem cells to support 2 courses of chemotherapy are required. Autologous bone marrow is collected as an adjuvant if stem cell harvest is inadequate.
Patients then receive high dose cisplatin, etoposide, and cyclophosphamide over 10 days, followed the next day by infusion of one fourth of the allotted stem cells, with the remaining allotment infused 2 days later. G-CSF is given for granulocyte support.
Beginning no sooner than 14 weeks from the start of the first course of chemotherapy, stable and responding patients receive high dose paclitaxel, carboplatin, and ifosfamide over 5 days, followed 2 days later with one-fourth of the allotted stem cells, with the remaining allotment infused the following day. G-CSF is given for granulocyte support. Groups of 3-6 patients are treated with escalating doses of paclitaxel until the maximum tolerated dose for this regimen is determined.
Patients are followed monthly for 1 year, every 3 months for 1 year, then as needed at the physician's discretion for at least 5 years.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose of paclitaxel studied.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sequential high dose chemotherapy paclitaxel - Sequential high dose chemotherapy cisplatin - Sequential high dose chemotherapy peripheral blood stem cell transplantation - Sequential high dose chemotherapy etoposide - Sequential high dose chemotherapy filgrastim - Sequential high dose chemotherapy cyclophosphamide - Sequential high dose chemotherapy carboplatin - Sequential high dose chemotherapy ifosfamide - Sequential high dose chemotherapy mesna -
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of two cycles of high dose chemothearpy and stem cell reinfusion 30 days from start of course II of treatment Feasibility of two cycles of high dose chemotherapy with stem cell reinfusion 30 days from start of course II of treatment Toxicity of two cycles of high dose chemothearpy and stem cell reinfusion 30 days from start of course II of treatment Toxicity graded according to the NCI Common Toxicity Criteria and amended for subjects undergoing transplantation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States