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Tandem Autologous Peripheral Blood Stem Cell Transplantation (PBSCT) After High Dose Paclitaxel Followed by Ifosfamide, Carboplatin, and Etoposide (ICE) for the Treatment of Lung Cancer


Phase 2
N/A
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

Tandem Autologous Peripheral Blood Stem Cell Transplantation (PBSCT) After High Dose Paclitaxel Followed by Ifosfamide, Carboplatin, and Etoposide (ICE) for the Treatment of Lung Cancer


OBJECTIVES: I. Evaluate the response rate of high dose chemotherapy followed by autologous
peripheral blood stem cell transplantation in the treatment of lung cancer.

OUTLINE: Patients undergo stem cell harvesting. Patients receive radiation therapy to
primary site and metastatic sites, if necessary. Patients receive a high dose of paclitaxel
by 24 hour continuous infusion, then stem cells are infused 72 hours later. After a 3-4 week
recovery period, patients receive ifosfamide and carboplatin by daily continuous infusion on
days -7, -6, -5, and -4. Etoposide is administered by continuous infusion twice daily on
days -7, -6, -5, and -4. Stem cells are again infused on day 0. Filgrastim (granulocyte
colony-stimulating factor; G-CSF) begins on day 0. Patients may receive radiotherapy
following recovery from chemotherapy. Patients are followed weekly for the first 6 months,
then periodically for at least 2 years.

PROJECTED ACCRUAL: This study will accrue 30 patients in 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically diagnosed lung cancer including
the following: Relapsed limited stage small cell lung cancer (SCLC) Limited stage SCLC
responding to conventional radiotherapy Extensive stage SCLC Stage IIIB and IV non-small
cell lung cancer (NSCLC) Stages II-IIIA NSCLC who are unable or unwilling to undergo
surgery but are acceptable candidates for high dose chemotherapy Cryopreserved peripheral
blood stem cells with CD34 count greater than 2000/mm3 No untreated or uncontrolled brain
metastases

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5
times normal SGOT less than 1.5 times normal Renal: Creatinine clearance greater than 50
mL/min Pulmonary: Left ventricular ejection fraction greater than 45% DLCO greater than
40% Other: Not pregnant or lactating No medical or psychiatric illness preventing informed
consent or intensive treatment

PRIOR CONCURRENT THERAPY: Concurrent chemotherapy allowed if no evidence of disease
progression

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David G. Savage, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066206

NCT ID:

NCT00003284

Start Date:

January 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • limited stage small cell lung cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Lung Neoplasms

Name

Location
Herbert Irving Comprehensive Cancer Center New York, New York  10032