RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating patients with lung cancer.

Condition	Treatment or Intervention	Phase
extensive stage small cell lung cancer limited stage small cell lung cancer stage IIIA non-small cell lung cancer stage IV non-small cell lung cancer stage II non-small cell lung cancer Recurrent Small Cell Lung Cancer stage IIIB non-small cell lung cancer	Drug: carboplatin  Drug: etoposide  Drug: filgrastim  Drug: ifosfamide  Drug: paclitaxel	Phase II

Further Study Details: 

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

PROTOCOL 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.

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• Concurrent chemotherapy allowed if no evidence of disease progression

--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

New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

Study chairs or principal investigators

David G. Savage,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

Study ID Numbers:  CDR0000066206; CPMC-IRB-7836; NCI-G98-1408; CU-CAMP-017
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003284
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08