VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
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ClinicalTrials.gov Identifier: NCT00025129 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific | Drug: laromustine | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer |
Study Start Date : | March 2001 |
Actual Study Completion Date : | May 2004 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025129
United States, Arizona | |
Arizona Clinical Research Center | |
Tucson, Arizona, United States, 85712 | |
United States, Connecticut | |
Yale Comprehensive Cancer Center | |
New Haven, Connecticut, United States, 06520-8028 | |
Veterans Affairs Medical Center - West Haven | |
West Haven, Connecticut, United States, 06516 |
Study Chair: | Mario Sznol, MD | Vion Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00025129 |
Other Study ID Numbers: |
VION-CLI-011 CDR0000068919 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-V01-1669 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | July 18, 2013 |
Last Verified: | March 2004 |
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 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 |
Lymphoma Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |