LymphomaPhase 1NCT00025129
VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
A Phase 1 study testing laromustine in people with Lymphoma and Small Intestine Cancer, run by Vion Pharmaceuticals at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- laromustine
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Mar 2001to May 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
Arizona Clinical Research Center
Tucson, Arizona, 85712
Veterans Affairs Medical Center - West Haven
West Haven, Connecticut, 06516
About this study
Official title: A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer
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.
Read the 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.
- Being tested
- laromustine
- 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, 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
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphoma, T-Cell, Cutaneous, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laromustineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2001
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Vion Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mario Sznol, MD, Study chair, Vion Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025129
- Sponsor's protocol ID
- VION-CLI-011
- Other IDs
- CDR0000068919, NCI-V01-1669
- Status last verified
- Mar 2004
- First submitted
- 11 Oct 2001
- Last updated
- 18 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT00025129
- Acronym / sponsor ID
- VION-CLI-011
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Vion PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Study completion
- May 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laromustine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Sznol, MD study chair
Vion Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing laromustine in people with Lymphoma and Small Intestine Cancer, run by Vion Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2013; AzTrials last refreshed its copy on 26 Oct 2026.