VNP40101M in Treating Patients With Advanced Solid Tumors... | NCT00025129 | Trialant
NCT00025129
Sponsor
Vion Pharmaceuticals
Status
Completed
Last Update Posted
Jul 18, 2013Estimated
Enrollment
Not provided
Phase
Phase 1
Conditions
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
laromustine
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
NCT00025129
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VION-CLI-011
Secondary IDs
ID
Type
Description
Link
CDR0000068919
Registry Identifier
PDQ (Physician Data Query)
NCI-V01-1669
Brief Title
VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
Official Title
A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Mar 2004
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
Mar 2001
Primary Completion Date
Not provided
Completion Date
May 2004Actual
First Submitted Date
Oct 11, 2001
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 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
Jul 17, 2013
Last Update Posted Date
Jul 18, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Vion PharmaceuticalsINDUSTRY
Collaborators
Not provided
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 cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced solid tumors or lymphomas.
Detailed Description
OBJECTIVES:
Determine the maximum tolerated dose of VNP40101M in patients with advanced solid tumors or lymphomas.
Determine the toxic effects of this drug in these patients.
Determine the pharmacokinetics of this drug in these patients.
Determine the anti-tumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive VNP40101M IV over 15 minutes on day 1. Treatment repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
Conditions Module
Conditions
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
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
small intestine lymphoma
unspecified adult solid tumor, protocol specific
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
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
laromustine
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed advanced and/or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists
Measurable or evaluable metastatic disease
No other hematologic malignancy
No large pleural, pericardial, or peritoneal effusions
No requirement for immediate palliative treatment, including surgery
No symptomatic brain metastases or metastases with substantial edema
Asymptomatic brain metastases or primary CNS disease allowed if neurologic deficits are stable
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-1
Life expectancy:
At least 3 months
Hematopoietic:
Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hematocrit at least 30% (transfusion allowed)
No active uncontrolled bleeding
Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver or bone metastases present)
PT and aPTT no greater than 1.5 times ULN
Albumin at least 2.5 g/dL
Renal:
Creatinine no greater than 2.0 mg/dL
Cardiovascular:
Ejection fraction at least 45%
No active heart disease
No myocardial infarction within the past 3 months
No symptomatic coronary artery disease
No arrhythmias requiring medication
No uncontrolled congestive heart failure
Pulmonary:
DLCO and FEV_1 at least 60% of predicted
No dyspnea with minimal to moderate exertion
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation
HIV negative
No active infection
Persistent stable chronic toxic effects from prior therapy allowed if no greater than grade 1
No bleeding diathesis (e.g., active peptic ulcer disease)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 3 weeks since prior biologic agents and recovered
At least 6 months since prior high-dose chemotherapy regimen with stem cell support
Chemotherapy:
See Biologic therapy
At least 3 weeks since prior cytotoxic agents (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy:
At least 2 weeks since prior hormonal therapy and recovered
Radiotherapy:
At least 3 weeks since prior radiotherapy and recovered
Surgery:
See Disease Characteristics
At least 2 weeks since prior surgery and recovered
Other:
No other concurrent standard therapy for cancer
No other concurrent investigational agents
No concurrent disulfiram (Antabuse)
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
Mario Sznol, MD
Vion Pharmaceuticals
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Arizona Clinical Research Center
Tucson
Arizona
85712
United States
Yale Comprehensive Cancer Center
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
D008223
Lymphoma
D006689
Hodgkin Disease
D016410
Lymphoma, T-Cell, Cutaneous
D008224
Lymphoma, Follicular
D008228
Lymphoma, Non-Hodgkin
D016403
Lymphoma, Large B-Cell, Diffuse
D016400
Lymphoma, Large-Cell, Immunoblastic
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D002051
Burkitt Lymphoma
D054218
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D064090
Intraocular Lymphoma
D020522
Lymphoma, Mantle-Cell
D007119
Immunoblastic Lymphadenopathy
D017728
Lymphoma, Large-Cell, Anaplastic
D009182
Mycosis Fungoides
D012751
Sezary Syndrome
D018442
Lymphoma, B-Cell, Marginal Zone
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C483604
laromustine
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
primary central nervous system non-Hodgkin lymphoma
intraocular lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
stage IV mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue