CompletedPhase 2NCT00020202
Official study title

FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer

Study 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 FR901228 in treating patients who have refractory or progressive small cell lung cancer or non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedFR901228

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 4, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
National Cancer Institute (NCI)
Interventions being studied
Drug: FR901228
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed primary extensive stage small cell or unresectable non-small cell lung cancer Must have received or refused prior platinum-based chemotherapy and exhibited refractory or progressive disease Tumor must be accessible to biopsy by bronchoscopic or percutaneous fine needle aspiration technique Measurable disease outside of irradiated field or documented progression since irradiation Extrathoracic metastases allowed No active intracranial or leptomeningeal metastases Prior surgical resection or radiotherapy for intracranial metastatic disease allowed if: No evidence of active disease on 2 MRI scans AND No requirement for anticonvulsant medications or steroids to control residual symptoms --Prior/Concurrent Therapy-- Biologic therapy: At least 30 days since prior biologic therapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy, including nitrosoureas or mitomycin, and recovered No prior FR901228 No prior doxorubicin of total dose greater than 450 mg/m2 Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 30 days since prior radiotherapy and recovered At least 4 weeks since prior radiotherapy to the lung or mediastinum Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: PT/PTT normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: Ejection fraction greater than 40% No unstable angina, congestive heart failure, or uncontrolled cardiac dysrhythmia No deep vein thrombosis requiring anticoagulation Pulmonary: No pulmonary embolism within past 6 months FEV1 and DLCO greater than 30% predicted pCO2 less than 50 mm Hg on room air pO2 greater than 60 mm Hg on room air Other: HIV negative No active infections Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Surgery BranchBethesda, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 4, 2024. Always confirm current availability with the study team.

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