Cell Genesys' Phase I/II Study of GM-CSF Gene-modified Autologous Tumor Vaccines in Early and Advanced Stage Non-Small Cell Lung Cancer (NSCLC)

Title:
Phase I/II Study of GM-CSF Gene-modified Autologous Tumor Vaccines in Early and Advanced Stage Non-Small Cell Lung Cancer (NSCLC)

Trial Identification Number:
Cell Genesys: D-9902

Protocol Objectives:

• Evaluate the feasibility of isolation and genetic modification of Autologous NSCLC cells to secrete GM-CSF by adenoviral based gene transfer for use as tumor vaccines.
• Evaluate the safety and efficacy of vaccination with Autologous NSCLC cells engineered to secrete GM-CSF in early and advanced stage NSCLC.

Study Design
Open label, outpatient Phase I/II, multicenter, clinical trial. Patients will be enrolled in two cohorts (early stage and advanced disease) and will receive 6 vaccinations every two weeks over a 3 month period with an additional 6 months of post vaccination follow up.

Sample Size


• Cohort A: Up to 60 early stage NSCLC following primary resection
• Cohort B: Up to 20 advanced stage NSCLC with accessible source of tumor

Patient Eligibility:


Eligibility Criteria for Tumor Procurement
Cohort A

• Suspicious diagnosis of IB/IIA/IIB NSCLC with planned primary surgical resection
• No pre or post operative chemotherapy or radiotherapy

Cohort B

• Histologically confirmed Stage IIIA/IIIB/IV NSCLC
• Accessible tumor source for vaccine production
• >4 weeks from chemotherapy or radiotherapy
• No prior radiotherapy to the site of tumor procurement

Cohort A and B

• No previous biologic, immunologic, or gene therapy for cancer
• No serious comorbid illnesses
• ECOG 0-1
• Age > 18
• Estimated life expectancy > 6 months
Eligibility Criteria for vaccine treatment
Cohort A and B

• Histologically confirmed diagnosis of NSCLC
• Successful tumor vaccine production

Investigational Product
Autologous GM-CSF secreting vaccine cells

Dose and Schedule
Vaccine dose will be based on total vaccine yield and will be individualized for each patient. All vaccinations will be administered intradermally (ID = under the skin) every 2 weeks for a total of 6 vaccinations.


Participating Clinical Trial Sites:
Portland, Oregon
Providence Portland Medical Center

Dallas, Texas
U.S. Oncology
3535 Worth St.
5th Floor, Collins Bldg.
Dallas, TX 75246
Sharon Barry
Phone: (214) 820-8799

Tyler, Texas
Tyler Cancer Center
910 E. Manning Blvd.
Tyler, TX 75702
Lynne Stein
Phone: (903) 592-6114

Albany, New York
Albany Cancer Center
317 S. Manning Blvd.
Ste. #330
Albany, NY 12208
Michelle Butler
Phone: (518) 489-2607

Orlando, Florida
Cancer Centers of Florida
52 West Gore Street
Orlando, FL 32806
Shawen Ilaria
Phone: (407)426-8484 ext. #202

San Francisco, California
University of California San Francisco / Mt. Zion
Department of Surgery
1600 Divisadero St., Rm. C322
San Francisco, CA 94115
Bob Kuhn
Phone: (415) 885-7333

Stanford, California
Stanford School of Medicine
CVRB Upper Level North
Stanford, CA 94305-5407
Pat Grant
Phone: (650) 725-3815

Philadelphia, Pennsylvania
University of Pennsylvania Medical Center
16 Penn Tower
4300 Spruce Street
Philadelphia, PA 19104-6160
Adri Recio
Phone: (215) 662-6392

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