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Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation Clinical research trials and Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation. Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation clinical trial. Human subjects frequently get the finest healthcare available for their Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation  Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
For Condition: Drug Toxicity,primary systemic amyloidosis
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining melphalan with a chemoprotective drug such as amifostine followed by peripheral stem cell transplantation may protect normal cells from the side effects of chemotherapy and 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 combining amifostine with melphalan in treating patients who are undergoing peripheral stem cell transplantation for primary systemic amyloidosis.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) of high-dose melphalan administered with amifostine in patients with primary systemic amyloidosis undergoing autologous peripheral blood stem cell transplantation. - Determine the toxicity of high-dose melphalan when administered at the MTD in these patients. - Determine the response rate in patients treated with this regimen. 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 5 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 at day 100 post-transplantation, every 6 months for 5 years and then annually for 5 years. PROJECTED ACCRUAL: A total of 3-46 patients will be accrued for this study within 2.3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed amyloidosis - No secondary familial or localized amyloidosis - Presence of monoclonal protein by immunoelectrophoresis or immunofixation of serum or urine - No primary amyloidosis manifested only by carpal tunnel syndrome or purpura - 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: - Hepatomegaly - Cardiomyopathy - Nephrotic range proteinuria - Peripheral or autonomic neuropathy - No multiple myeloma defined by 1 of the following: - Presence of lytic bone disease - More than 30% bone marrow plasma cells PATIENT CHARACTERISTICS: Age - 18 to 70 Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Platelet count at least 100,000/mm^3 Hepatic - See Disease Characteristics - Total or direct bilirubin no greater than 2.0 mg/dL - Alkaline phosphatase no greater than 4 times upper limit of normal Renal - See Disease Characteristics - Creatinine less than 3.0 mg/dL Cardiovascular - See Disease Characteristics - Ejection fraction at least 45% by echocardiogram - No New York Heart Association class III or IV heart disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active infection - No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or indolent prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior interferon Chemotherapy - At least 4 weeks since prior melphalan - Lifetime total melphalan dose less than 150 mg/m^2 (based on ideal body weight) Endocrine therapy - At least 4 weeks since prior dexamethasone Radiotherapy - No prior radiotherapy for amyloidosis Surgery - Not specified Other - No antihypertensive medications for at least 24 hours prior to, during, and for 1 hour after amifostine administration - No other prior treatment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MorieGertz, Study Chair, Mayo Clinic - Rochester
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Rafat Abonour 317-274-0843
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Scott Rowley 201-996-5900
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Morie Gertz 507-284-2511
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Hillard Lazarus 216-844-3629
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Edward Stadtmauer 215-662-7910
Additional Information:
Study ID Numbers: CDR0000258785; ECOG-2A01
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052884
Other Primary Systemic Amyloidosis Studies:
1. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
2. Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
3. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
4. Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis
5. Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
Related Studies:
Other primary systemic amyloidosis Clinical Trials
Other New Jersey Clinical Trials
Other Hackensack Clinical Trials
Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
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