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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00776295
• Other study ID #: MCC 14955
• Status: Terminated
• Phase: Phase 2
• First received: October 20, 2008
• Last updated: January 16, 2013
• Start date: May 2007
• Est. completion date: August 2010

Study information

• Verified date: January 2013
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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%.

Other known NCT identifiers

• NCT00609583

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	HLeeMoffitt	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Meeting 1-year Overall Survival	Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death	up to one year	No
Secondary	3 Year Progression-free Survival	3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC	up to 3 years	No

External Links

•   H. Lee Moffitt Cancer Center & Research Institute