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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: | Allocation: Non-Randomized Primary Purpose: Treatment |
| 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 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| 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 | |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| 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 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Park Nicollet Cancer Center | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| Minnesota Oncology Hematology, PA - Woodbury | |
| Woodbury, Minnesota, United States, 55125 | |
| 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
| ClinicalTrials.gov Identifier: | NCT00052884 History of Changes |
| Other Study ID Numbers: | CDR0000258785, ECOG-E2A01 |
| Study First Received: | January 24, 2003 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
|
drug/agent toxicity by tissue/organ primary systemic amyloidosis |
|
Amyloidosis Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Proteostasis Deficiencies Metabolic Diseases Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Amifostine Melphalan Lenograstim Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Antineoplastic Agents Therapeutic Uses |
