High-Dose Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Lung Cancer
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: filgrastim Drug: carboplatin Drug: etoposide Drug: ifosfamide Drug: paclitaxel Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 1998 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| Study Chair: | David G. Savage, MD | Herbert Irving Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003284 History of Changes |
| Other Study ID Numbers: | CDR0000066206, CPMC-IRB-7836, CU-CAMP-017, NCI-G98-1408 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Etoposide Paclitaxel Etoposide phosphate Isophosphamide mustard Ifosfamide Carboplatin Lenograstim |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Tubulin Modulators Antimitotic Agents Mitosis Modulators Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013