VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer

Conditions
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Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: laromustine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: laromustine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, 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, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma