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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
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



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