A Cancer Vaccine (CG8123) Given With and Without Cyclophosphamide for Advanced Stage Non-Small Cell Lung Cancer (NSCLC)

December 18, 2007 updated by: Cell Genesys

A Phase II Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) With and Without Low-Dose Cyclophosphamide in Advanced Stage Non-Small Cell Lung Cancer

The main purpose of this research study is to determine if a vaccine made from a patient's lung cancer tumor cells will be effective in making the cancer shrink or disappear. The vaccine will be given by itself to some patients, while other patients will get the vaccine with cyclophosphamide (a type of chemotherapy). Studies in animals and other cancer vaccine trials suggest that cyclophosphamide may make tumor vaccines more potent. This study will try to determine if vaccine given with or without this chemotherapy is effective in destroying lung cancer cells. Additionally, the study will collect information on vaccine safety, both with and without chemotherapy, and whether the vaccine improves lung cancer-related symptoms (e.g., shortness of breath).

Tumors from surgical resection will be processed and made into a vaccine. Prior to treatment, patients will be randomized equally to one of two treatment groups, Cohort A and Cohort B. Patients in Cohort A will be treated with CG8123 vaccine only and patients in Cohort B will be treated with CG8123 vaccine plus a single dose of cyclophosphamide administered one day prior to the first, third, and fifth vaccine treatments. Patients will receive intradermal (beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of up to five vaccine treatments. The duration of this study, including active follow up, is approximately two years. After this, patients will be followed-up yearly for a total of 15 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Suspicious diagnosis of or histologically- confirmed stage IIIB or IV non small-cell lung cancer
  • Accessible and adequate tumor source for vaccine production.
  • Tumor source for vaccine production must be accessible by a minor surgical procedure performed under local or regional anesthesia (e.g. lymph node or soft tissue mass or malignant pleural effusion)
  • Measurable disease to evaluate following tumor procurement
  • Limited metastatic tumor burden
  • Life expectancy at least 4 months
  • ECOG Performance Status 0 - 1

Exclusion Criteria:

  • Active and/or untreated brain metastases
  • Active or impending spinal cord compression
  • Active auto-immune disease or treatment with immunosuppressants
  • Decompensated congestive heart failure or recent significant cardiac event
  • Coexisting malignancies
  • Significant or uncontrolled medical problems or laboratory abnormalities that might increase the risk of surgical complications or vaccine treatment
  • Previous treatment with gene therapy (including any adenoviral-based therapy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cell Genesys

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

August 11, 2004

First Submitted That Met QC Criteria

August 11, 2004

First Posted (Estimate)

August 12, 2004

Study Record Updates

Last Update Posted (Estimate)

December 24, 2007

Last Update Submitted That Met QC Criteria

December 18, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-0031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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