Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer
OBJECTIVES:
- Determine the frequency and duration of response in patients with recurrent small cell
lung cancer treated with interferon alfa, isotretinoin, and paclitaxel.
- Determine the toxic effects of this regimen in these patients.
- Determine the duration of survival in patients treated with this regimen.
- Correlate the levels of bcl-2 in peripheral blood monocytes with response and survival
in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive interferon alfa subcutaneously and oral isotretinoin on days 1 and 2 and
paclitaxel IV over 1 hour on day 2 of weeks 1-6. Courses repeat every 8 weeks in the absence
of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response by RECIST Criteria (v 1.0)
Number of eligible, treated participants in each response category by RECIST criteria
Assessed every 6 weeks
No
Joseph Aisner, MD
Study Chair
Cancer Institute of New Jersey
United States: Federal Government
CDR0000304430
NCT00062010
February 2004
August 2012
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
| Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
| Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
| HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
| Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
| HealthEast Cancer Care at St. Joseph's Hospital | St Paul, Minnesota 55102 |
| Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
| HealthEast Cancer Care at Woodwinds Health Campus | Woodbury, Minnesota 55125 |
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
| St. Rita's Medical Center | Lima, Ohio 45801 |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
| Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
| West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston, West Virginia 25302 |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
| Adena Regional Medical Center | Chillicothe, Ohio 54601 |
| Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Grady Memorial Hospital | Delaware, Ohio 43015 |
| Fairfield Medical Center | Lancaster, Ohio 43130 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
| Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Howard Community Hospital | Kokomo, Indiana 46904 |
| Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
| Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
| Mercy Capitol Hospital | Des Moines, Iowa 50307 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
| Mercy Medical Center | Springfield, Ohio 45504 |
| Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
| Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
| Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
| Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |