Expired Study
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Buffalo, New York 14263


Purpose:

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have non-small cell lung cancer.


Study summary:

OBJECTIVES: - Determine the safety and feasibility of immunization with autologous tumor lysate-pulsed dendritic cell vaccine in patients with non-small cell lung cancer. - Determine the immunologic response in patients treated with this vaccine. OUTLINE: Patients undergo surgery to remove all or most of the gross evidence of tumor. Two months after surgery (or 4 months if chemotherapy and/or radiotherapy are required), patients undergo leukapheresis. Peripheral blood mononuclear cells are isolated and cultured with interleukin-4 and sargramostim (GM-CSF) to generate dendritic cells (DC). DC are then pulsed with tumor lysate prepared from previously removed tumor. Patients receive autologous tumor lysate-pulsed DC vaccine subcutaneously twice, 4 weeks apart. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of operable stage IB, II, or IIIA non-small cell lung cancer - Tumor diameter of at least 3 cm PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST less than 2 times upper limit of normal (ULN) - Lactate dehydrogenase less than 2 times ULN - Hepatitis B and C negative Renal: - Creatinine no greater than 1.4 mg/dL Other: - Positive cell mediated immunity test (i.e., greater than 5 mm induration in 48 hours with purified protein derivative (of tuberculin), candida, and mumps intradermal injection skin test) - HIV negative - No active systemic infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biological materials Chemotherapy: - At least 4 weeks since prior cytotoxic or chemotherapeutic agents - Concurrent chemotherapy allowed after surgery and before vaccination Endocrine therapy: - No concurrent steroid therapy Radiotherapy: - At least 4 weeks since prior radiotherapy - Concurrent radiotherapy allowed after surgery and before vaccination Surgery: - See Disease Characteristics


Study is Available At:


Original ID:

CDR0000068881


NCT ID:

NCT00023985


Secondary ID:

RPCI-RP-9907


Study Acronym:


Brief Title:

Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer


Official Title:

Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Roswell Park Cancer Institute


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Timothy M. Anderson, MD
Study Chair
Roswell Park Cancer Institute

Study Dates

Start Date:January 2001
Completion Date:August 2003
Completion Type:Actual
Primary Completion Date:July 2003
Primary Completion Type:Actual
Verification Date:March 2011
Last Changed Date:March 3, 2011
First Received Date:September 13, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:autologous tumor cell vaccine
Intervention Type:Biological
Name:therapeutic autologous dendritic cells
Intervention Type:Procedure
Name:conventional surgery

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Roswell Park Cancer Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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