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CompletedNCT00098085Updated Mar 9, 2009

Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer

A Phase 2 interventional study of HSPPC-96 in Non-Small-Cell Lung Carcinoma, Lung Cancer and Pulmonary Cancer, sponsored by Agenus Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-09.

Sponsored by Agenus Inc. · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

All patients will undergo surgery to remove the tumor and will be followed for recurrence and overall survival.

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.

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

HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent to Antigenics' manufacturing facility where it will undergo processing to create a vaccine. This vaccine may help the patient's immune system attack cancerous cells while leaving healthy cells alone.

02

Conditions studied

  • Non-Small-Cell Lung Carcinoma
  • Lung Cancer
  • Pulmonary Cancer

Keywords

  • Lung cancer
  • Non-small cell lung cancer
  • Pulmonary
  • Immunotherapy
  • Vaccine
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 20 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Agenus Inc. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 3 (27%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

This is a summary of criteria. Only the Principal Investigator can determine eligibility.

Inclusion criteria

Inclusion Criteria:

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants

Interventions

06

What researchers measure

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.

07

Study locations

1 site
  • London, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2003 and a primary completion of Nov 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2004
First posted
Dec 6, 2004
Start
Sep 2003
Primary completionActual
Nov 2007
Last update
Mar 9, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00098085
Lead sponsor
Agenus Inc.
First posted
Dec 6, 2004
Start date
Sep 2003
Primary completion
Nov 2007
Last update
Mar 9, 2009
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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