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

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CG8123

Biological

Cyclophosphamide

Drug

Sponsors and collaborators

Lead sponsor

Cell Genesys

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Study completion: 2006
First posted: Aug 12, 2004
Registry last updated: Dec 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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