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Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fenretinide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) after platinum-containing chemotherapy regimen with or without thoracic radiotherapy Limited stage or extensive stage SCLC Measurable disease At least 20 mm by conventional techniques OR At least 10 mm with spiral CT scan No pleural effusions, bone metastases, brain metastases, or abnormal radionucleotide scans as sole evidence of disease No symptomatic or uncontrolled brain or leptomeningeal disease Previously treated brain metastases allowed if neurologically stable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Hematopoietic: WBC at least 2,500/mm^3 Platelet count at least 70,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic heart disease No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 1 month before, during, and for 2 months after study No pre-existing retinal degenerative disease (e.g., retinitis pigmentosa or associated disorders) No other serious concurrent illness No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Chemotherapy: At least 3 weeks since prior chemotherapy No more than 2 prior chemotherapy regimens Endocrine therapy: Concurrent steroids allowed at stable dose Radiotherapy: No prior radiotherapy to study lesions Other: At least 3 weeks since prior systemic retinoid or carotenoid therapy No concurrent anticonvulsants

Sites / Locations

  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients receive oral fenretinide twice daily on days 1-7. Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00009971
Brief Title
Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
Official Title
Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2003
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description
OBJECTIVES: I. Determine the efficacy of fenretinide, in terms of complete and partial response rates, duration of response, and survival, in patients with recurrent small cell lung cancer. II. Determine the toxicity of this regimen in these patients. III. Correlate the induction of apoptosis or the expression of molecular mediators of apoptosis in tumor cells with response rates, response duration, and survival in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive oral fenretinide twice daily on days 1-7. Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral fenretinide twice daily on days 1-7. Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
fenretinide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) after platinum-containing chemotherapy regimen with or without thoracic radiotherapy Limited stage or extensive stage SCLC Measurable disease At least 20 mm by conventional techniques OR At least 10 mm with spiral CT scan No pleural effusions, bone metastases, brain metastases, or abnormal radionucleotide scans as sole evidence of disease No symptomatic or uncontrolled brain or leptomeningeal disease Previously treated brain metastases allowed if neurologically stable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Hematopoietic: WBC at least 2,500/mm^3 Platelet count at least 70,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic heart disease No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 1 month before, during, and for 2 months after study No pre-existing retinal degenerative disease (e.g., retinitis pigmentosa or associated disorders) No other serious concurrent illness No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Chemotherapy: At least 3 weeks since prior chemotherapy No more than 2 prior chemotherapy regimens Endocrine therapy: Concurrent steroids allowed at stable dose Radiotherapy: No prior radiotherapy to study lesions Other: At least 3 weeks since prior systemic retinoid or carotenoid therapy No concurrent anticonvulsants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory P. Kalemkerian, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0752
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

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Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer

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