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Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Temozolomide
Temozolomide
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring TEMOZOLOMIDE, Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • 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.

Sites / Locations

  • Memoral Sloan Kettering Cancer Center
  • Memorial Sloan-Kettering Cancer Center at Commack
  • Memorial Sloan-Kettering Cancer Center
  • Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
  • Memoral Sloan Kettering Cancer Center@Phelps

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

75 mg/m2/day Temozolomide

200 mg/m2/day Temozolomide

Arm Description

75 mg/m2/day Temozolomide for 21 days (7 days off treatment). 28 day cycles.

200 mg/m2/day Temozolomide for 5 days (23 days off treatment). 28 day cycles.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 22, 2008
Last Updated
July 1, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00740636
Brief Title
Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer
Official Title
Phase II Study of Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Schering-Plough

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
TEMOZOLOMIDE, Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
75 mg/m2/day Temozolomide
Arm Type
Experimental
Arm Description
75 mg/m2/day Temozolomide for 21 days (7 days off treatment). 28 day cycles.
Arm Title
200 mg/m2/day Temozolomide
Arm Type
Experimental
Arm Description
200 mg/m2/day Temozolomide for 5 days (23 days off treatment). 28 day cycles.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 200mg/m2/day.
Primary Outcome Measure Information:
Title
The Objective Overall Response
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Pietanza, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoral Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Memoral Sloan Kettering Cancer Center@Phelps
City
Sleepy Hollow
State/Province
New York
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

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