CompletedPhase 2NCT00740636

Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

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.

Checked against the public recordLast updated Aug 1, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations5
SponsorMemorial Sloan Kettering Cancer Center
01
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
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

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 * 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. 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.

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

  • 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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