High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer
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.
Procedure: peripheral blood stem cell transplantation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PHASE I PILOT STUDY OF SEQUENTIAL HIGH DOSE CYCLES OF CISPLATIN, CYCLOPHOSPHAMIDE, ETOPOSIDE AND IFOSFAMIDE, CARBOPLATIN AND TAXOL WITH AUTOLOGOUS STEM CELL SUPPORT|
- Feasibility of two cycles of high dose chemotherapy with stem cell reinfusion [ Time Frame: 30 days from start of course II of treatment ] [ Designated as safety issue: Yes ]
- Toxicity of two cycles of high dose chemothearpy and stem cell reinfusion [ Time Frame: 30 days from start of course II of treatment ] [ Designated as safety issue: Yes ]Toxicity graded according to the NCI Common Toxicity Criteria and amended for subjects undergoing transplantation
- Maximum tolerated dose of two cycles of high dose chemothearpy and stem cell reinfusion [ Time Frame: 30 days from start of course II of treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 1994|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
|Experimental: Sequential high dose chemotherapy||Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: ifosfamide Drug: mesna Drug: paclitaxel Procedure: peripheral blood stem cell transplantation|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002854
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Study Chair:||George Somlo, MD||City of Hope Comprehensive Cancer Center|