NCT00025129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2001

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

July 18, 2013

Status Verified

March 1, 2004

First QC Date

October 11, 2001

Last Update Submit

July 17, 2013

Conditions

LymphomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomasmall intestine lymphomaunspecified adult solid tumor, protocol specificstage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaprimary central nervous system non-Hodgkin lymphomaintraocular lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

laromustineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Veterans Affairs Medical Center - West Haven

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

laromustine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsNeoplasms by SiteLymphadenopathyLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mario Sznol, MD

    Vion Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Study Completion

May 1, 2004

Last Updated

July 18, 2013

Record last verified: 2004-03

Locations

US(3)