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Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

Phase II Study of Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

NCT00740636•Memorial Sloan Kettering Cancer Center

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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
+4 more criteria

Exclusion 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.

Locations (5)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, United States

Memoral Sloan Kettering Cancer Center@Phelps

Sleepy Hollow, New York, United States

Key Dates

Start Date

August 1, 2008

Primary Completion Date

February 1, 2013

Completion Date

February 1, 2013

Last Updated

August 1, 2016

Enrollment

ACTUAL participants

Conditions

Lung Cancer

Interventions

Temozolomide

DRUG

Temozolomide

DRUG

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

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