Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer
Phase II Study of Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer
1 other identifier
interventional
92
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lung-cancer
Started Aug 2008
Typical duration for phase_2 lung-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
February 1, 2016
CompletedAugust 1, 2016
June 1, 2016
4.5 years
August 22, 2008
October 20, 2015
July 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Objective Overall Response
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.
2 years
Study Arms (2)
75 mg/m2/day Temozolomide
EXPERIMENTAL75 mg/m2/day Temozolomide for 21 days (7 days off treatment). 28 day cycles.
200 mg/m2/day Temozolomide
EXPERIMENTAL200 mg/m2/day Temozolomide for 5 days (23 days off treatment). 28 day cycles.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Schering-Ploughcollaborator
Study Sites (5)
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, 11725, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570, United States
Memoral Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Maria C. Pietanza
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Pietanza, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2008
First Posted
August 25, 2008
Study Start
August 1, 2008
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
August 1, 2016
Results First Posted
February 1, 2016
Record last verified: 2016-06