Arsenic Trioxide in Treating Patients With Advanced Hemat... | NCT00003395 | Trialant
NCT00003395
Sponsor
Memorial Sloan Kettering Cancer Center
Status
Completed
Last Update Posted
Jun 25, 2013Estimated
Enrollment
Not provided
Phase
Phase 1
Conditions
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Interventions
arsenic trioxide
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00003395
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
98-023
Secondary IDs
ID
Type
Description
Link
CDR0000066395
Registry Identifier
PDQ (Physician Data Query)
NCI-G98-1449
Brief Title
Arsenic Trioxide in Treating Patients With Advanced Hematologic Cancer
Official Title
Dose-Ranging Study of Arsenic Trioxide in Advanced Hematologic Cancers
Acronym
Not provided
Organization
Memorial Sloan Kettering Cancer CenterOTHER
Status Module
Record Verification Date
Jun 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 1998
Primary Completion Date
Mar 2000Actual
Completion Date
Mar 2000Actual
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Aug 13, 2004
First Posted Date
Aug 16, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 24, 2013
Last Update Posted Date
Jun 25, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Memorial Sloan Kettering Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced hematologic cancer.
Detailed Description
OBJECTIVES: I. Develop a safe, weight-based, extended-dosing regimen of arsenic trioxide suitable for outpatient therapy in patients with advanced hematologic cancers. II. Determine the pattern of clinical adverse experience in patients treated with this drug. III. Evaluate evidence of clinical responsiveness that may provide leads for further testing in patients treated with this drug.
OUTLINE: This is a dose-escalation study. Patients receive arsenic trioxide IV over 1-4 hours on days 1-25. Courses repeat every 3-5 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Patients are followed for 1 month.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
Conditions Module
Conditions
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
refractory multiple myeloma
Waldenström macroglobulinemia
stage III multiple myeloma
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
arsenic trioxide
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven hematologic cancer, including acute or chronic leukemia, malignant lymphoma, or multiple myeloma Exclude acute promyelocytic leukemia (M3) Relapse from or resistance to at least one course of standard anticancer therapy and lack of alternative therapy that has proven to be curative in the underlying disease
PATIENT CHARACTERISTICS: Age: 17 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.5 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception during and for at least 4 months after study No history of grand mal seizures (other than infantile febrile seizures) No active serious infections that are not controlled by antibiotics
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
17 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Steven Soignet, MD
Memorial Sloan Kettering Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Memorial Sloan-Kettering Cancer Center
New York
New York
10021
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D007938
Leukemia
D008223
Lymphoma
D009101
Multiple Myeloma
D054219
Neoplasms, Plasma Cell
D006689
Hodgkin Disease
D016410
Lymphoma, T-Cell, Cutaneous
D008258
Waldenstrom Macroglobulinemia
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D015470
Leukemia, Myeloid, Acute
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D015466
Leukemia, Myeloid, Chronic-Phase
D015465
Leukemia, Myeloid, Accelerated Phase
D001752
Blast Crisis
D004915
Leukemia, Erythroblastic, Acute
D015479
Leukemia, Myelomonocytic, Acute
D007948
Leukemia, Monocytic, Acute
D015472
Leukemia, Eosinophilic, Acute
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D000077237
Arsenic Trioxide
Ancestor Terms
ID
Term
D001152
Arsenicals
D007287
Inorganic Chemicals
D010087
Oxides
D017601
Oxygen Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
adult acute erythroid leukemia (M6)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)