NCT00621036

Brief Summary

RATIONALE: Vaccines made from a person's cancer proteins may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may make a stronger immune response and kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving vaccine therapy together with GM-CSF works in treating patients with CNS lymphoma.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 19, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2008

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

February 21, 2008

Last Update Submit

November 21, 2018

Conditions

Brain and Central Nervous System TumorsLymphomaLymphoproliferative DisorderSmall Intestine Cancer

Keywords

primary central nervous system non-Hodgkin lymphomaprimary central nervous system Hodgkin lymphomastage IV adult T-cell leukemia/lymphomaadult nasal type extranodal NK/T-cell lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuestage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage IV mycosis fungoides/Sezary syndromestage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomaintraocular lymphomapost-transplant lymphoproliferative disordercutaneous B-cell non-Hodgkin lymphomaWaldenström macroglobulinemiasmall intestine lymphoma

Outcome Measures

Primary Outcomes (2)

  • Anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) immune response rate in the CSF

  • Safety and tolerability

Secondary Outcomes (4)

  • Progression-free survival (PFS)

  • Time to receipt of first subsequent anti-lymphoma therapy after initiating immunization with the Id-KLH conjugate vaccine

  • Correlation of anti-Id immune response in the CSF and/or serum with PFS and overall survival

  • Kinetics of humoral immune response development

Study Arms (1)

methotrexate IV once every 2 weeks

EXPERIMENTAL
Biological: autologous immunoglobulin idiotype-KLH conjugate vaccineBiological: sargramostimDrug: methotrexateDrug: thiotepaRadiation: radiation therapy

Interventions

autologous immunoglobulin idiotype-KLH conjugate vaccineBIOLOGICAL
methotrexate IV once every 2 weeks
sargramostimBIOLOGICAL
methotrexate IV once every 2 weeks
methotrexateDRUG
methotrexate IV once every 2 weeks
thiotepaDRUG
methotrexate IV once every 2 weeks
radiation therapyRADIATION
methotrexate IV once every 2 weeks

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or CSF cytologically confirmed CNS lymphoma with any of the following clinical histories: * Primary CNS lymphoma at initial diagnosis * Primary CNS lymphoma at relapse * Systemic lymphoma with CNS disease at initial diagnosis or at relapse * Adequate fresh tissue or cell pellet available for analysis by Genitope Corporation to determine adequacy for idiotype (Id) manufacturing * Tumor must express both functional light and heavy chain genes * No tumors known or found to be surface immunoglobulin negative * Not in leukemic phase (i.e., \> 5,000/mm³ circulating tumor cells) PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100% * WBC ≥ 1,500/mm³ * Platelet count ≥ 75,000/mm³ * Hemoglobin ≥ 10 g/dL * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's disease) * Creatinine ≤ 1.5 times ULN * Able to undergo placement of an Ommaya reservoir * Able to receive induction therapy (chemotherapy with or without brain radiotherapy) with intent to induce remission * Speaks English or Spanish * No other malignancy within the past 3 years, except adequately treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ * Not pregnant or nursing * No immunosuppressive viral infections as evidenced by HIV antibody or antigen, hepatitis B antigen, or hepatitis C antibody or antigen positivity * No history of autoimmune disease that required treatment within the past 5 years, including previously treated autoimmune hemolytic anemia or immune thrombocytopenia PRIOR CONCURRENT THERAPY: * More than 30 days since prior and no concurrent participation in another therapeutic clinical trial * More than 2 weeks since prior steroids * No concurrent immunosuppressives, including corticosteroids * Transient use of optical or nasal steroid solutions is allowed * No other concurrent anticancer therapy or therapy for non-Hodgkin lymphoma

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

Sponsors & Collaborators

Study Sites (1)

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsLymphomaLymphoproliferative DisordersPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellIntraocular LymphomaWaldenstrom Macroglobulinemia

Interventions

sargramostimMethotrexateThiotepaRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic TypeLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, T-CellLymphadenopathyEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEye NeoplasmsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhosphoramidesOrganophosphorus CompoundsOrganic ChemicalsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingTherapeutics

Study Officials

  • Elizabeth Maher, MD, PhD

    Simmons Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2008

First Posted

February 22, 2008

Study Start

October 19, 2007

Primary Completion

December 8, 2008

Study Completion

December 8, 2008

Last Updated

November 26, 2018

Record last verified: 2018-11

Locations

US(1)