Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Subjects Meeting 1-year Overall Survival

Outcome Description:

Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death

Outcome Time Frame:

up to one year

Safety Issue:

No

Principal Investigator

Mohamed Kharfan-Dabaja, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

MCC 14955

NCT ID:

NCT00776295

Start Date:

May 2007

Completion Date:

August 2010

Related Keywords:

  • Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • SCLC
  • Limited Stage Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

HLeeMoffittTampa, Florida  33612