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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052884 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher dose of chemotherapy to be given so that more plasma cells are killed. Giving a chemoprotective drug such as amifostine may protect kidney cells from the side effects of chemotherapy.
PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Multiple Myeloma and Plasma Cell Neoplasm |
Biological: filgrastim Drug: amifostine trihydrate Drug: melphalan Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Active Control |
| Official Title: | A Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis |
| Estimated Enrollment: | 46 |
| Study Start Date: | October 2003 |
OBJECTIVES:
OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of melphalan.
Patients receive filgrastim (G-CSF) subcutaneously once daily until peripheral blood stem cell (PBSC) collection is complete. Apheresis begins on day 5 of G-CSF administration and continues until the target number of PBSCs are collected.
Within 6 weeks of PBSC collection, patients receive amifostine IV over 5 minutes on days -2 and -1 and high-dose melphalan IV over 30-60 minutes on day -1. Patients undergo autologous PBSC infusion on day 0.
Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose.
Patients are followed approximately 3 months following transplantation, then every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 3-46 patients will be accrued for this study within 2.3 years.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed amyloidosis
Amyloid deposits in a plasmacytoma or in bone marrow vessels in an asymptomatic individual not considered an amyloid syndrome
Amyloid syndromes include any of the following:
No multiple myeloma defined by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Minnesota Oncology Hematology, PA - Maplewood | |
| Maplewood, Minnesota, United States, 55109 | |
| Minnesota Oncology Hematology, PA - Woodbury | |
| Woodbury, Minnesota, United States, 55125 | |
| Park Nicollet Cancer Center | |
| St. Louis Park, Minnesota, United States, 55416 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Ohio | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | Morie A. Gertz, MD | Mayo Clinic |
| Investigator: | Philip R. Greipp, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000258785, ECOG-E2A01 |
| Study First Received: | January 24, 2003 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00052884 History of Changes |
| Health Authority: | United States: Federal Government |
|
drug/agent toxicity by tissue/organ primary systemic amyloidosis |
|
Melphalan Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Neoplasms by Histologic Type Metabolic Diseases |
Immunoproliferative Disorders Immune System Diseases Amifostine Hematologic Diseases Vascular Diseases Protective Agents Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Neoplasms Amyloidosis Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Neoplasms, Plasma Cell |