Chloroquinoxaline Sulfonamide in Treating Patients With Small Cell Lung Cancer

Sponsor

City of Hope Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00008372

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of chloroquinoxaline sulfonamide in treating patients who have small cell lung cancer that has not responded to platinum-based chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: chloroquinoxaline sulfonamide	Phase 2

Detailed Description

OBJECTIVES: I. Determine the efficacy of chloroquinoxaline sulfonamide in patients with platinum-refractory small cell lung cancer. II. Determine the toxic effects of this drug in these patients.

OUTLINE: Patients receive chloroquinoxaline sulfonamide IV over 1 hour once a week for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed until death.

PROJECTED ACCRUAL: A total of 12-38 patients will be accrued for this study within 12-18 months.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Phase II Trial Of CQS (NSC 339004) In Platinum-Refractory Small Cell Lung Cancer

Study Start Date :

Dec 1, 2000

Actual Primary Completion Date :

Sep 1, 2002

Actual Study Completion Date :

Sep 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically confirmed platinum-refractory small cell lung cancer No response or progression during or within 6 months of completing platinum based therapy Measurable disease No symptomatic brain or leptomeningeal metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 No hemolytic anemia Hepatic: Bilirubin normal AST no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of cardiac arrhythmias Other: No other active malignancy requiring concurrent treatment No allergy to sulfonamides Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: No concurrent corticosteroids to control symptoms of brain and/or leptomeningeal metastases Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy to measurable lesions Surgery: Not specified Other: No concurrent hypoglycemic agents (including insulin)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center and Beckman Research Institute, City of Hope	Duarte	California	United States	91010-3000
2	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033-0804
3	University of California Davis Cancer Center	Sacramento	California	United States	95817