NCT00003082

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibodies in treating patients who have advanced cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 1997

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

July 19, 2004

Completed
Last Updated

March 16, 2010

Status Verified

May 1, 2007

Enrollment Period

3.2 years

First QC Date

November 1, 1999

Last Update Submit

March 12, 2010

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesPrecancerous/Nonmalignant ConditionUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomamonoclonal gammopathy of undetermined significancerecurrent adult Hodgkin lymphomaisolated plasmacytoma of boneextramedullary plasmacytomarefractory multiple myelomaWaldenstrom macroglobulinemiastage III multiple myelomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiaunspecified adult solid tumor, protocol specificchronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionpolycythemia verachronic idiopathic myelofibrosisessential thrombocythemiauntreated hairy cell leukemiaprogressive hairy cell leukemia, initial treatmentrefractory hairy cell leukemiachronic myelomonocytic leukemiaT-cell large granular lymphocyte leukemiaacute undifferentiated leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage 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 III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesprolymphocytic leukemiaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaprimary systemic amyloidosisstage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone 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

monoclonal antibody A27.15BIOLOGICAL
monoclonal antibody E2.3BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Refractory or recurrent advanced malignancy following known standard effective therapy or advanced malignancy for which no standard effective therapy exists Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count at least 1800/mm3 Hematocrit at least 30 mg/dL Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal unless due to disease, then less than 3.5 times normal Transaminases less than 3 times upper limit of normal (ULN) (less than 5 times ULN if due to liver metastases) Renal: Creatinine no greater than 2.5 times normal Cardiovascular: No severe cardiac abnormalities Must have adequate venous access No history of sustained ventricular arrhythmia or unexplained syncope Pulmonary: No severe pulmonary abnormalities Other: Not pregnant or nursing Effective contraception required of fertile female patients No serious concurrent medical or psychiatric illness Adequate nutrition No human antimouse antibodies PRIOR CONCURRENT THERAPY: At least 4 weeks since prior anticancer therapy and recovered If there was disease progression during therapy, at least 2 weeks since prior anticancer therapy and recovered Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Concurrent topical steroids used in the chronic management of cutaneous T cell lymphoma allowed No other concurrent hormone therapy Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesPrecancerous ConditionsHodgkin DiseaseMonoclonal Gammopathy of Undetermined SignificanceWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisPolycythemia VeraPrimary MyelofibrosisThrombocythemia, EssentialLeukemia, Hairy CellLeukemia, Myelomonocytic, ChronicLeukemia, Large Granular LymphocyticLeukemia, Biphenotypic, AcuteLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, ProlymphocyticImmunoglobulin Light-chain AmyloidosisLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersHypergammaglobulinemiaLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersMyelodysplastic-Myeloproliferative DiseasesLeukemia, T-CellLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphadenopathyLymphoma, T-Cell

Study Officials

  • Michael Lobell, MD

    University of Arizona

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 19, 2004

Study Start

December 1, 1997

Primary Completion

February 1, 2001

Study Completion

February 1, 2001

Last Updated

March 16, 2010

Record last verified: 2007-05

Locations

US(1)