High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors; Breast Cancer; Ewing's Family of Tumors; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Ovarian Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: amifostine trihydrate (Drug); cyclophosphamide (Drug); filgrastim (Drug); melphalan (Drug); biological therapy (Procedure); bone marrow ablation with stem cell support (Procedure); chemoprotection (Procedure); chemotherapy (Procedure); peripheral blood stem cell transplantation (Procedure); supportive care/therapy (Procedure)
Phase: Phase 1/Phase 2
Status: No longer recruiting
Sponsored by: University of Kentucky Official(s) and/or principal investigator(s):
Donna E. Reece, MD, Study Chair, Affiliation: University of Kentucky
Summary
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 doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation and amifostine in treating patients with cancer.
Clinical Details
Official title:
Phase I/II Study of Escalating Dose Melphalan With Autologous Pluripotent Hematopoietic Stem Cell Support and Amifostine Cytoprotection in Cancer Patients
Study design: Interventional, Treatment
Detailed description:
OBJECTIVES: I. Determine the maximum tolerated dose of high dose melphalan with autologous peripheral blood stem cell support and amifostine cytoprotection in patients with cancer. II. Determine the complete response rate, event free survival, overall survival, and nonrelapse mortality in this patient population.
OUTLINE: This is a dose escalation study of melphalan. Prior to high dose melphalan and amifostine cytoprotection, patients may receive cyclophosphamide IV. Filgrastim (G-CSF) is given until cytapheresis is completed. Patients receive high dose melphalan according to an escalating dose schedule. High dose melphalan is administered IV on day - 1. Amifostine is also administered on days -2 and -1. Peripheral blood stem cell transplantation is performed on day 0. Dose escalation of high dose melphalan continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity. After the MTD of high dose melphalan is determined, additional patients are treated at this dose level. Patients are followed at days 30, 100, 365, and yearly thereafter.
PROJECTED ACCRUAL: After the determination of MTD, a total of 14-25 patients will be accrued for this study.
Eligibility
Minimum age: 14 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Confirmed diagnosis of primary tumor and/or recurrence that has a low curative potential using other therapies, including but not limited to: Acute leukemia Myeloma Breast cancer Ovarian cancer Hodgkin's disease Non-Hodgkin's lymphoma Neuroblastoma Ewing's sarcoma In the absence of recurrence, malignancies for which an autotransplant regimen is considered a reasonable therapeutic alternative are also considered Greater than 25% of bone marrow normal cellularity and less than 10% of volume composed of tumor cells No active brain metastases or carcinomatous meningitis (controlled CNS metastases eligible)
PATIENT CHARACTERISTICS: Age: 14 to 70 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3000/mm3 Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin, SGOT, and SGPT less than 2 times normal Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF at least 45% Pulmonary: DLCO at least 50% FEV1 at least 60% Other: Not pregnant or nursing Fertile patients must use effective contraception HIV, HTLV-1, and HTLV-2 negative Hepatitis B and C negative
PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior autologous peripheral blood stem cell transplant Chemotherapy: Cumulative anthracycline or equivalent dose no greater than 450 mg/m2 Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Recovered from prior therapy No antihypertensives during and 24 hours prior to amifostine administration
Locations and Contacts
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky 40536-0084, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland 21201, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5541, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Related publications: Phillips GL, Meisenberg BR, Reece DE, Adams VR, Badros AZ, Brunner JL, Fenton RG, Filicko J, Grosso DL, Hale GA, Howard DS, Johnson VP, Kniska A, Marshall KW, Mookerjee B, Nath R, Rapoport AP, Sarkodee-Adoo C, Takebe N, Vesole DH, Wagner JL, Flomenberg N. Activity of single-agent melphalan 220-300 mg/m2 with amifostine cytoprotection and autologous hematopoietic stem cell support in non-Hodgkin and Hodgkin lymphoma. Bone Marrow Transplant. 2004 Apr;33(8):781-7.
Starting date:
July 1999
Last updated: April 9, 2007
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