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Chloroquinoxaline Sulfonamide in Treating Patients With Small Cell Lung Cancer

NCT ID: NCT00008372

Last Updated: 2011-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2002-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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chloroquinoxaline sulfonamide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Primo N. Lara, MD

Role: STUDY_CHAIR

University of California, Davis

Locations

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Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-PHII-26

Identifier Type: -

Identifier Source: secondary_id

NCI-57

Identifier Type: -

Identifier Source: secondary_id

CDR0000068401

Identifier Type: REGISTRY

Identifier Source: secondary_id

00104

Identifier Type: -

Identifier Source: org_study_id