NCT00005628

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1999

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

November 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

April 2, 2004

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

May 2, 2000

Last Update Submit

June 18, 2013

Conditions

Sarcoma

Keywords

recurrent adult soft tissue sarcomastage IV adult soft tissue sarcoma

Interventions

vitespenBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed recurrent soft tissue sarcoma Incompletely or completely resected metastatic or locally recurrent disease (surgery must be performed with intent of complete resection) No active brain metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: At least 16 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 80,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infections requiring antibiotics within 2 weeks of study No other serious medical illness requiring hospitalization No history of primary or secondary immunodeficiency or autoimmune disease No contraindications to MRI (e.g., aneurysm clips or cardiac pacemakers) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy and recovered Chemotherapy: At least 6 weeks since prior chemotherapy and recovered Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 6 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics No prior splenectomy Other: At least 6 weeks since other prior experimental anticancer therapy and recovered No concurrent non-steroidal anti-inflammatory drugs or other immunosuppressive drugs No other concurrent participation in a clinical trial

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

Sarcoma

Interventions

vitespin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Robert Maki, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

April 2, 2004

Study Start

November 1, 1999

Primary Completion

August 1, 2001

Study Completion

August 1, 2001

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)