ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Lucille P. Markey Cancer Center at University of Kentucky
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003425
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Neuroblastoma
Ovarian Cancer
Sarcoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: amifostine trihydrate
Drug: cyclophosphamide
Drug: filgrastim
Drug: melphalan
Procedure: peripheral blood stem cell transplantation
Phase I
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    breast cancer    hemophilia   

MedlinePlus related topics:   Breast Cancer    Cancer    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Multiple Myeloma    Neuroblastoma    Ovarian Cancer    Soft Tissue Sarcoma   

ChemIDplus related topics:   Cyclophosphamide    Filgrastim    Melphalan    Melphalan hydrochloride    Sarcolysin    Amifostine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I/II Study of Escalating Dose Melphalan With Autologous Pluripotent Hematopoietic Stem Cell Support and Amifostine Cytoprotection in Cancer Patients

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   25
Study Start Date:   December 1997

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
Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003425

Locations
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky    
      Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland    
      Baltimore, Maryland, United States, 21201
United States, Pennsylvania
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia    
      Philadelphia, Pennsylvania, United States, 19107-5541
United States, Wisconsin
Medical College of Wisconsin    
      Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators
Lucille P. Markey Cancer Center at University of Kentucky

Investigators
Study Chair:     Donna E. Reece, MD     Lucille P. Markey Cancer Center at University of Kentucky    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000066448, UKMC-97BMT72, ALZA-UKMC-97BMT72, NCI-V98-1455
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003425
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
stage IV breast cancer  
stage IIIA breast cancer  
recurrent breast cancer  
stage IIIB breast cancer  
recurrent adult Hodgkin lymphoma  
refractory plasma cell neoplasm  
stage III ovarian epithelial cancer  
stage IV ovarian epithelial cancer  
recurrent ovarian epithelial cancer  
regional neuroblastoma  
disseminated neuroblastoma  
stage 4S neuroblastoma  
recurrent neuroblastoma  
stage III multiple myeloma
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
unspecified adult solid tumor, protocol specific
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
ovarian stromal cancer
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
acute undifferentiated leukemia
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Hodgkin lymphoma, adult
Malignant mesenchymal tumor
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Urogenital Neoplasms
Ovarian epithelial cancer
Lymphoma, large-cell, immunoblastic
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Hemorrhagic Disorders
Multiple myeloma
Neoplasm Metastasis
Neuroepithelioma
Acute myeloid leukemia, adult
Hodgkin Disease
Breast Diseases
Endocrine Gland Neoplasms
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Blood Coagulation Disorders
Acute myelogenous leukemia
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Leukemia, Myeloid
Multiple Myeloma

Additional relevant MeSH terms:
Radiation-Protective Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on September 16, 2008




Links to all studies - primarily for crawlers