NCT00003959

Brief Summary

RATIONALE: A vaccine made from a person's myelodysplasia cells may make the body build an immune response to kill cancer cells. Combining vaccine therapy with sargramostim may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have myelodysplastic syndrome.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1 leukemia

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

March 15, 2004

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

2.5 years

First QC Date

November 1, 1999

Last Update Submit

January 15, 2013

Conditions

LeukemiaMyelodysplastic Syndromes

Keywords

refractory anemiarefractory anemia with ringed sideroblastsrefractory anemia with excess blastschronic myelomonocytic leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromes

Interventions

ras peptide cancer vaccineBIOLOGICAL
sargramostimBIOLOGICAL

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven myelodysplastic syndrome (MDS) with 1 of the following classifications: Refractory anemia Refractory anemia with ringed sideroblasts Refractory anemia with excess blasts Chronic myelomonocytic leukemia History of MDS, received chemotherapy for acute leukemia within past 12 months, and now in remission Myelodysplastic disease must be stable (not anticipated to require chemotherapy for at least 4 months) Must have 1 of the following N-, K-, or H-ras peptide mutations: Progenitor cells contain aspartic acid, valine, or serine substitution at codon 12, OR Aspartic acid or arginine substitution at codon 13 PATIENT CHARACTERISTICS: Age: Over 17 Performance status: ECOG 0 or 1 Life expectancy: Greater than 5 months Hematopoietic: WBC at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Not specified Renal: Not specified Cardiovascular: No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Fertile patients must use effective contraception No other medical condition that might prevent completion of study or prevent immunological response to study regimen No other concurrent serious medical illness No active bleeding PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent immunosuppressive drugs including systemic steroids or antiinflammatory drugs Radiotherapy: No prior irradiation of spleen Surgery: No prior splenectomy

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesAnemia, RefractoryAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, Chronic

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesAnemiaLeukemia, MyeloidMyelodysplastic-Myeloproliferative DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen D. Nimer, MD

    Memorial Sloan Kettering Cancer Center

    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

March 15, 2004

Study Start

June 1, 1999

Primary Completion

December 1, 2001

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)