NCT00004024

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and radiation therapy in treating patients who have primary or recurrent astrocytoma or oligodendroglioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 1997

Longer than P75 for phase_2

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

June 1, 1997

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

6.6 years

First QC Date

November 1, 1999

Last Update Submit

April 3, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult subependymomaadult oligodendrogliomaadult giant cell glioblastomaadult gliosarcomaadult diffuse astrocytoma

Interventions

aldesleukinBIOLOGICAL
autologous tumor cell vaccineBIOLOGICAL
muromonab-CD3BIOLOGICAL
sargramostimBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
surgical procedurePROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven grade II, III, or IV astrocytoma or oligodendroglioma * Evidence of primary or recurrent tumor by MRI * Resectable disease * At least 20,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0 or 1 Life expectancy: * At least 6 months Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least lower limit of normal * No active or recent uncontrolled bleeding Hepatic: * Bilirubin normal * SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Renal: * Creatinine normal Other: * Able to be weaned off steroids * Negative stool guaiac * No impaired immunity * No uncontrolled diabetes * No active uncontrolled infections * No other serious disease * No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix * No psychological, familial, sociological, or geographical conditions that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No concurrent chemotherapy except for progressive disease Endocrine therapy: * See Disease Characteristics Radiotherapy: * Radium implants allowed Surgery: * Not specified Other * At least 1 week since prior therapy and recovered

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

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Publications (1)

  • Sloan AE, Dansey R, Zamorano L, Barger G, Hamm C, Diaz F, Baynes R, Wood G. Adoptive immunotherapy in patients with recurrent malignant glioma: preliminary results of using autologous whole-tumor vaccine plus granulocyte-macrophage colony-stimulating factor and adoptive transfer of anti-CD3-activated lymphocytes. Neurosurg Focus. 2000 Dec 15;9(6):e9. doi: 10.3171/foc.2000.9.6.10.

    PMID: 16817692RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaOligodendrogliomaGlioma, SubependymalGliosarcoma

Interventions

aldesleukinFANG vaccineMuromonab-CD3sargramostimSurgical Procedures, OperativeRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEpendymoma

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsImmunoglobulin GImmunoglobulin IsotypesSerum GlobulinsGlobulinsTherapeutics

Study Officials

  • Andrew E. Sloan, MD

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

June 1, 1997

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

US(1)