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

NCT00776295 | Terminated Phase 2 Results DMC

• 1 other identifier: MCC 14955
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Small Cell Lung Cancer

Keywords

Small Cell Lung Cancer; SCLC; Limited Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 3 Year Progression-free Survival

  up to 3 years

Study Arms (1)

adeno virus vectored p53

EXPERIMENTAL

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

Interventions

Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes BIOLOGICAL

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

adeno virus vectored p53

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

HLeeMoffitt

Tampa, Florida, 33612, United States

Location

Related Links

• H. Lee Moffitt Cancer Center \& Research Institute

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Early termination of trial due to small number of subjects thus leading to unreliabe data

Results Point of Contact

• Title: Mohamed Kharfan Dabaja, MD
• Organization: H. Lee Moffitt Cancer Center

MK143@aub.edu.lb

961-1350000

Study Officials

• Mohamed Kharfan-Dabaja, MD

  H. Lee Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: May 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 24, 2013
• Results First Posted: June 21, 2012

Record last verified: 2013-01

Locations

US (1)