High-Dose Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003284
First received: November 1, 1999
Last updated: January 3, 2014
Last verified: June 2000

November 1, 1999
January 3, 2014
January 1998
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Complete list of historical versions of study NCT00003284 on ClinicalTrials.gov Archive Site
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High-Dose Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Lung Cancer
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

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Lung Cancer
  • Biological: filgrastim
  • Drug: carboplatin
  • Drug: etoposide
  • Drug: ifosfamide
  • Drug: paclitaxel
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
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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

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003284
CDR0000066206, CPMC-IRB-7836, CU-CAMP-017, NCI-G98-1408
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Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: David G. Savage, MD Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
June 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP