Know Cancer

forgot password

Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer


- 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.

Inclusion Criteria

Inclusion Criteria

- Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC)
with clinically confirmed measurable disease

- Age 18 and over

- ECOG Performance status 0-3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 1.5 mg/dL

- AST no greater than 2 times upper limit of normal (ULN)

- Creatinine no greater than 1.5 mg/dL

- Triglycerides no greater than 1.5 times ULN

- Patients must have had prior chemotherapy treatment for SCLC, and toxicities must
have resolved to less than or equal to grade 1

- Women of childbearing potential and sexually active males are strongly encouraged to
use an accepted and effective method of contraception.

Exclusion Criteria

- History of another neoplasm other than SCLC except for non-metastatic, non-melanoma
skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or small
field radiotherapy at least 5 years before registration

- Pregnant or nursing, with a negative pregnancy test within 2 weeks prior to

- Severe depression requiring medication

- Use of the following drugs within 4 weeks prior to registration: carbamazepine,
ethanol, tetracycline, doxycycline, minocycline, topical acne products containing
Retin-A, vitamin A, cisplatin, ketoconazole, phenytoin or other antiepileptic drugs

- Use of GM-CSF or G-CSF within 4 weeks prior to registration

- Prior paclitaxel or interferon therapy

- Radiation therapy within 60 days prior to registration

- Chemotherapy within 60 days prior to registration

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response by RECIST Criteria (v 1.0)

Outcome Description:

Number of eligible, treated participants in each response category by RECIST criteria

Outcome Time Frame:

Assessed every 6 weeks

Safety Issue:


Principal Investigator

Joseph Aisner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Federal Government

Study ID:




Start Date:

February 2004

Completion Date:

August 2012

Related Keywords:

  • Lung Cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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