NCT00098085

Brief Summary

Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with resectable non-small cell lung cancer. Vaccine production will be attempted on all patients who undergo surgery and meet all inclusion/exclusion criteria.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

March 9, 2009

Status Verified

March 1, 2009

Enrollment Period

4.2 years

First QC Date

December 3, 2004

Last Update Submit

March 6, 2009

Conditions

Non-Small-Cell Lung CarcinomaLung CancerPulmonary Cancer

Keywords

Lung cancerNon-small cell lung cancerPulmonaryImmunotherapyVaccine

Outcome Measures

Primary Outcomes (1)

  • The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer.

Secondary Outcomes (1)

  • The secondary goals are to further characterize the safety and efficacy profile, to evaluate disease recurrence in patients, and to evaluate overall survival in patients receiving HSPPC-96.

Interventions

HSPPC-96BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected non-small cell lung cancer, Stage IB, Stage II, or Stage IIIA
  • Tumor size \> 3x3 cm or equivalent to a 9 cm² lesion
  • Scheduled surgery with curative intent
  • At least 18 years of age
  • Must not be pregnant or breast feeding
  • Agree to not receive any other investigative agent at any time while enrolled in this study

You may not qualify if:

  • Previous treatment for non-small cell lung cancer
  • Clinical signs or symptoms of brain metastases
  • History of immune suppression or autoimmune disorder
  • Severe active infection or other serious medical illness, that in the opinion of the Principal Investigator, would prevent study completion
  • Other malignancies in the past 5 years, except adequately treated in situ cervix carcinoma or non-melanoma skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

vitespin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2004

First Posted

December 6, 2004

Study Start

September 1, 2003

Primary Completion

November 1, 2007

Last Updated

March 9, 2009

Record last verified: 2009-03

Locations

GB(1)