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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Temozolomide

Drug

Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 75 mg/m2/day.

Primary outcomes

The Objective Overall Response

Time frame: 2 years

The objective response is defined as all complete responses and partial responses based on the modified RECIST.Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

Schering-Plough

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Aug 25, 2008
Registry last updated: Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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