Viewing Study NCT00085345



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Last Modification Date: 2024-10-26 @ 9:10 AM
Study NCT ID: NCT00085345
Status: WITHDRAWN
Last Update Posted: 2013-07-10
First Post: 2004-06-10

Brief Title: Melphalan Arsenic Trioxide and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor: Oncotherapeutics
Organization: National Cancer Institute NCI

Study Overview

Official Title: Phase II Study of Melphalan Arsenic Trioxide and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma
Status: WITHDRAWN
Status Verified Date: 2006-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Drugs used in chemotherapy such as melphalan arsenic trioxide and ascorbic acid work in different ways to stop cancer cells from dividing so they stop growing or die Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs

PURPOSE This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma
Detailed Description: OBJECTIVES

Primary

Determine the time to progression in patients with relapsed or refractory multiple myeloma MM treated with melphalan arsenic trioxide and ascorbic acid
Determine the response rate combined complete response partial response and minimal response in patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients

Secondary

Determine the time to response and overall survival of patients treated with this regimen
Determine the effects of this regimen on renal failure associated with MM in these patients

OUTLINE This is an open-label non-randomized multicenter study

Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide ATO IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice weekly during weeks 2-5 Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with disease progression any time after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy and receive no further therapy Patients achieving stable disease or a partial response after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly

Patients are followed every 3 months

PROJECTED ACCRUAL A total of 65 patients will be accrued for this study

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
CDR0000368637 REGISTRY PDQ Physician Data Query None