Study on Temozolomide With or Without Veliparib for Treating Relapsed or Resistant Small Cell Lung Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT01638546

This clinical trial is exploring whether the drug temozolomide, used alone or with another drug called veliparib, can effectively treat small cell lung cancer that has returned or is not responding to treatment.

Patient Parameters

Parameter	Options

Program Overview

This study is testing how well the drug temozolomide works, either by itself or combined with veliparib, in treating small cell lung cancer that has come back or isn't responding to treatment. Temozolomide damages the DNA inside cancer cells, which is necessary for their survival and growth. Veliparib may help by blocking proteins that repair this DNA damage, potentially making temozolomide more effective. The study aims to find out if adding veliparib improves treatment outcomes.

Description

The main goal of this study is to see if adding veliparib to temozolomide can improve the time patients live without their cancer getting worse, compared to using temozolomide with a placebo. Researchers will also look at how many patients' tumors shrink, how long patients live overall, and how safe and tolerable the treatment is.

The study will also explore whether certain genetic markers in tumor samples can predict how well patients respond to treatment. Researchers will collect and analyze tumor samples to study these markers and their relationship with treatment outcomes.

Participants will be randomly assigned to one of two groups:

Group 1 will receive veliparib and temozolomide.
Group 2 will receive a placebo and temozolomide.

Both groups will take their assigned medications in cycles of 28 days, as long as the cancer does not progress or side effects are manageable. After finishing the treatment, patients will have follow-up visits every 8-12 weeks.

Eligibility Criteria

Inclusion Criteria

Have a confirmed diagnosis of small cell lung cancer.
Cancer has returned or progressed after one or two previous chemotherapy treatments, including one with etoposide and platinum.
Be in relatively good health with an ECOG performance status of 0 or 1.
Have measurable cancer that can be tracked using scans.
Have adequate blood counts and organ function based on specific lab tests.
Women of childbearing potential and men must agree to use effective birth control during the study.
Be able to swallow pills.
Understand and agree to sign an informed consent form.
Patients with HIV/AIDS can participate if their CD4 counts are above 200 cells/mm³ and they are not on certain medications.

Exclusion Criteria

Have received chemotherapy or radiation within the last 3 weeks.
Have not recovered from side effects of previous treatments.
Have previously taken veliparib, any other PARP inhibitor, or temozolomide.
Have active seizures or a history of seizures.
Have severe allergic reactions to similar drugs.
Have uncontrolled illnesses or conditions that could interfere with the study.
Are pregnant or breastfeeding.
Are on combination antiretroviral therapy for HIV/AIDS.
Have another active cancer requiring treatment.

Locations

FACILITY	ZIP	CITY	STATE
Moffitt Cancer Center	33612	Tampa	Florida
Emory University Hospital/Winship Cancer Institute	30322	Atlanta	Georgia
Johns Hopkins Bayview Medical Center	21224	Baltimore	Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center	21287	Baltimore	Maryland
Washington University School of Medicine	63110	St Louis	Missouri
Memorial Sloan Kettering Basking Ridge	07920	Basking Ridge	New Jersey
Memorial Sloan Kettering Commack	11725	Commack	New York
Memorial Sloan Kettering Cancer Center	10065	New York	New York
Memorial Sloan Kettering Sleepy Hollow	10591	Sleepy Hollow	New York
Memorial Sloan Kettering Nassau	11553	Uniondale	New York

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.