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Phase I/II Study of High Dose Melphalan with Autologous Peripheral Blood Stem Cell Support and Amifostine Cytoprotection in Cancer Patients

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II, Phase I Supportive care, Treatment Closed 14 to 70 Pharmaceutical / Industry UKMC-97BMT72
ALZA-UKMC-97BMT72, NCI-V98-1455, NCT00003425

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.

Entry 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)

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

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

Expected Enrollment

After the determination of MTD, a total of 14-25 patients will be accrued for 
this study.

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.

Published Results

Phillips GL, Meisenberg BR, Reece DE, et al.: 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 33 (8): 781-7, 2004.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Lucille P. Markey Cancer Center at University of Kentucky

Donna Reece, MD, Protocol chair(Contact information may not be current)
Ph: 859-257-4500

Registry Information

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

Trial Start Date		1997-12-01

Registered in ClinicalTrials.gov		NCT00003425

Date Submitted to PDQ		1998-07-13

Information Last Verified		2005-06-21

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.