Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

Study summary

The purpose of this study is to determine whether treatment with temozolomide will shrink small cell lung cancer tumors. Temozolomide is an oral chemotherapy drug that is currently used to treat brain cancer and melanoma. As part of this study, we will be doing additional tests that may help us understand how temozolomide works. First, if there is a tumor sample from a biopsy done in the past, it will be analyzed for an abnormal gene that may be present in lung cancer. Before starting temozolomide, a research blood test will be done to look for the same abnormal gene we are looking for in your tumor sample. Also, before starting temozolomide and every time you have a repeat CT scan, a research blood test will be done to analyze the number of tumor cells in your bloodstream.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTemozolomide and Temozolomide

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 1, 2016 · 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?5 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Interventions being studied: Drug: Temozolomide; Drug: Temozolomide

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How this study is categorized

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

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Recurrent or relapsed→Resistant or refractory→

Treatment approach

Chemotherapy→

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

Patients must have pathologically confirmed SCLC at MSKCC that has progressed after one or two chemotherapy regimens.
At least 3 weeks must have elapsed since last chemotherapy or radiation treatment and initiation of study treatment.
Karnofsky performance status \> or = to 60%.
Patients must have measurable disease, this can include brain metastases.
Patients must have normal organ and marrow function as defined below:
\- leukocytes \> 3,000/mcL
platelets \> 100,000/mcL
total bilirubin \< 1.5 mg/dL
AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal
Creatinine \< 2.0 mg/dl
For women of child-bearing potential, negative pregnancy test within 7 days prior to starting temozolomide.
Men and women of childbearing potential must agree to practice adequate contraception.
Ability to understand and the willingness to sign a written informed consent document.
Both men and women of all races and ethnic groups are eligible for this trial.

Reasons someone may not be able to joinExclusion criteria

Patients who have not recovered from adverse events of previous therapies.
Patients receiving other investigational agents.
Patients with leptomeningeal involvement.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or HIV-positive patients on combination antiretroviral therapy. However, HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. Excluding patients on HAART is necessary due to the potential for pharmacokinetic interactions with temozolomide.
Women who are pregnant or breast feeding, due to possible adverse effects on the developing fetus or infant due to study drug.

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

Study sites

U.S. locations

Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey
Memorial Sloan-Kettering Cancer Center at CommackCommack, New York
Memorial Sloan-Kettering Cancer CenterNew York, New York
Memorial Sloan-Kettering Cancer Center at Mercy Medical CenterRockville Centre, New York
Memoral Sloan Kettering Cancer Center@PhelpsSleepy Hollow, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 1, 2016. Always confirm current availability with the study team.

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