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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

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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 CenterNew York, New York  10032