Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer

January 16, 2013 updated by: H. Lee Moffitt Cancer Center and Research Institute

Phase II Trial of Autologous Peripheral Blood Hematopoietic Cell Transplantation (PBHCT) Followed by Dendritic Cell p53 Vaccination and Adoptive T Cell Transfer in Patients With Limited Stage Small Cell Lung Cancer

The purpose of this study is to determine whether p53 vaccination followed by high dose chemotherapy and autologous HCT and T cell therapy significantly induces immune responses resulting in 1-year survival greater that the current 70%.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • HLeeMoffitt

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:

  • Histologically confirmed SCLC who presented with Limited Stage (LS) at diagnosis.
  • Measurable disease at the time of initial therapy
  • Appropriate treatment for LS-SCLC including radiotherapy and chemotherapy.
  • Responsive disease to standard chemoradiation therapy as defined by RECIST
  • Patients with CR after chemoradiation therapy are strongly recommended to be treated with prophylactic cranial irradiation
  • CBC with an absolute neutrophil count (ANC) >/= 1,000/uL, hemoglobin >/= 8.0 g/DL and platelet count >/= 75,000/uL.
  • Normal prothrombin time (PT) and partial thromboplastin time (aPTT), unless on monitored anticoagulation therapy for medical conditions not excluded in the trial.
  • Liver enzymes: total bilirubin less than or equal to 2mg/dL; AST and ALT less than 1.5X the upper limit of normal.
  • Creatinine clearance of >/= 60 mL/min
  • Pulmonary: DLCO greater than 50%
  • Cardiac: left ventricular ejection fraction greater than 45%

Exclusion Criteria:

  • Patient with stable (SD) or progressive disease (PD) after 4 cycles of standard cisplatin and etoposide and concurrent chest irradiation
  • Pregnant or lactating woman
  • HIV infection confirmed by NAT
  • Common variable immunodeficiency
  • Active CNS malignancy
  • Active bacterial, fungal or viral infection
  • Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care
  • Prior history of autologous or allogeneic hematopoietic cell transplantation
  • Presence of protocol specific comorbid conditions

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adeno virus vectored p53
Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Biological: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Autologous Dendritic Cells Derived from Peripheral Blood Mononuclear Cells, Cultured with Granulocyte-Macrophage Colony-Stimulating Factor and Interleukin 4, Transfected with Adenovirus Vector (Ad5CMV-p53, Introgen Therapeutics) Expressing Wildtype p53 Gene; Combined with Autologous Expanded T Lymphocytes (CD3+, CD4+, and CD8+), Cultured with OKT3 (Orthoclone) and Anti-CD28 (Repligen) Coated Magnetic Beads

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Meeting 1-year Overall Survival
Time Frame: up to one year
Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 Year Progression-free Survival
Time Frame: up to 3 years
3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC
up to 3 years

Collaborators and Investigators

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Mohamed Kharfan-Dabaja, MD, H. Lee Moffitt Cancer Center

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

May 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

October 20, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (Estimate)

October 21, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC 14955

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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