Pyroxamide in Treating Patients With Advanced Cancer | NCT00042900 | Trialant
NCT00042900
Sponsor
Memorial Sloan Kettering Cancer Center
Status
Completed
Last Update Posted
Jun 5, 2013Estimated
Enrollment
Not provided
Phase
Phase 1
Conditions
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous Condition
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
pyroxamide
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00042900
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
99-090
Secondary IDs
ID
Type
Description
Link
CDR0000069483
Registry Identifier
PDQ (Physician Data Query)
NCI-2110
Brief Title
Pyroxamide in Treating Patients With Advanced Cancer
Official Title
A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies
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 2002
Primary Completion Date
Sep 2002Actual
Completion Date
Sep 2002Actual
First Submitted Date
Aug 5, 2002
First Submission Date that Met QC Criteria
Jul 7, 2003
First Posted Date
Jul 8, 2003Estimated
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 4, 2013
Last Update Posted Date
Jun 5, 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 pyroxamide in treating patients who have advanced cancer.
Detailed Description
OBJECTIVES:
Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies.
Define, qualitatively and quantitatively, the dose-limiting and non-dose-limiting toxic effects of this drug in these patients.
Describe the pharmacologic behavior of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive pyroxamide IV continuously over 5-7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pyroxamide 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.
Patients are followed monthly for resolution of adverse events.
PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.
Conditions Module
Conditions
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous Condition
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
T-cell large granular lymphocyte leukemia
Waldenström macroglobulinemia
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
primary myelofibrosis
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
essential thrombocythemia
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
pyroxamide
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor or hematologic malignancy
Disease that has failed standard therapies (e.g., surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no curative or life- prolonging therapy is available
Measurable or clinically evaluable disease
Elevated tumor marker is acceptable for evaluable disease
No known carcinomatous meningitis, primary brain tumors, or metastatic brain disease
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2
Life expectancy
Not specified
Hematopoietic
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 125,000/mm^3
Hemoglobin at least 9.0 g/dL
Hepatic
Bilirubin normal
AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
PT no greater than 1.5 times ULN
Renal
Creatinine normal
Other
HIV-positive status allowed
Prior malignancy allowed
No severe physical or emotional illness that would preclude study participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent bone marrow growth factors
Chemotherapy
See Disease Characteristics
At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
See Disease Characteristics
Radiotherapy
See Disease Characteristics
At least 4 weeks since prior wide-field radiotherapy and recovered
At least 2 weeks since prior limited-field radiotherapy and recovered
Recovered from prior radiotherapy
Surgery
See Disease Characteristics
Other
No other concurrent antitumor treatment
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Leonard B. Saltz, 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.
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
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
extramedullary plasmacytoma
intraocular lymphoma
isolated plasmacytoma of bone
meningeal chronic myelogenous leukemia
monoclonal gammopathy of undetermined significance
polycythemia vera
previously treated myelodysplastic syndromes
primary central nervous system non-Hodgkin lymphoma