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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
N/A
Not Enrolling
Both
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


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.

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
registration

- 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:

Interventional

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:

No

Principal Investigator

Joseph Aisner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000304430

NCT ID:

NCT00062010

Start Date:

February 2004

Completion Date:

August 2012

Related Keywords:

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

Name

Location

Akron City HospitalAkron, Ohio  44304
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Northern New JerseyHackensack, New Jersey  07601
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
St. Rita's Medical CenterLima, Ohio  45801
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - ColumbusColumbus, Ohio  43206
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Mount Carmel Health - West HospitalColumbus, Ohio  43222
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Mercy Medical CenterSpringfield, Ohio  45504
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Grant Medical Center Cancer CareColumbus, Ohio  43215
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792