VNP40101M in Treating Patients With Advanced or Metastatic Cancer

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 or metastatic cancer.

Detailed Description
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OBJECTIVES: Determine the toxic effects of VNP40101M in patients with advanced or metastatic solid tumor or lymphoma. Determine the maximum tolerated dose of this drug in these patients. Determine the pharmacokinetics of this drug in these patients. Determine the antitumor effects of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive VNP40101M IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 28 days. Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose is determined. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Official Title
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A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly 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 or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists Measurable or evaluable disease Primary brain tumors or brain metastases allowed provided neurologic deficits are stable and do not preclude study compliance 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 bleeding diathesis Hepatic PT and PTT no greater than 1.5 times the upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present) Albumin at least 2.5 gm/dL Renal Creatinine no greater than 2.0 mg/dL Cardiovascular At least 3 months since prior myocardial infarction No symptomatic coronary artery disease No arrhythmias requiring medication No uncontrolled congestive heart failure Pulmonary No dyspnea on minimal or moderate exertion DLCO and FEV1 at least 60% predicted Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled active bleeding (e.g., active peptic ulcer disease) No active infection HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy Recovered from acute toxicities of prior biologic therapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) Chemotherapy More than 6 months since prior high-dose chemotherapy with stem cell support More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) Recovered from acute toxicities of prior chemotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) Endocrine therapy At least 2 weeks since prior hormonal therapy Radiotherapy Recovered from acute toxicities of prior radiotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) Surgery At least 2 weeks since prior surgery Other No other concurrent standard or investigational treatment for cancer No concurrent disulfiram

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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anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, intraocular lymphoma, primary central nervous system non-Hodgkin lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, small intestine lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV mycosis fungoides/Sezary syndrome, unspecified adult solid tumor, protocol specific, 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