Study on Topotecan and M6620 for Treating Small Cell Lung Cancer and Other Small Cell Cancers
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03896503
This clinical trial is testing whether adding the drug M6620 to the chemotherapy drug topotecan can improve treatment outcomes for patients with small cell lung cancer that has returned or small cell cancers that started outside the lungs.
Patient Parameters
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Program Overview
This study aims to find out if combining the drug M6620 with topotecan can help patients with small cell lung cancer (SCLC) that has come back, or small cell cancers that started in other parts of the body. Topotecan works by damaging the DNA in cancer cells, causing them to die. However, some cancer cells can repair this damage. M6620 may help by blocking the enzymes that repair DNA, potentially making topotecan more effective in shrinking tumors and preventing cancer from returning.
Description
The main goal of this study is to see if the combination of M6620 and topotecan can improve the time patients live without their cancer getting worse, compared to using topotecan alone. Researchers will also look at how many patients respond to the treatment and how long they live overall.
The study will also explore the genetic makeup of the cancer and normal tissues to find markers that might predict how well patients respond to the treatment. This includes analyzing genes and collecting data for future research.
Participants will be divided into two groups:
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Group 1 (SCLC patients): Some will receive only topotecan, while others will receive both topotecan and M6620. Treatment cycles repeat every 21 days unless the cancer progresses or side effects become too severe. Participants will have CT scans and may have tumor biopsies and blood samples taken.
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Group 2 (Patients with small cell cancers outside the lungs): All will receive both topotecan and M6620. Treatment cycles repeat every 21 days unless the cancer progresses or side effects become too severe. Participants will have CT scans and may have tumor biopsies and blood samples taken.
After finishing the treatment, patients will have follow-up visits at 4 weeks and then every 12 weeks.
Eligibility Criteria
Inclusion Criteria
- Must have small cell lung cancer (SCLC) that has returned or small cell cancer that started outside the lungs.
- Must be 18 years or older.
- Must have a performance status that allows for daily activities with some limitations.
- Must have adequate blood counts and organ function.
- Must not be pregnant and agree to use contraception during and after the study.
- Must have treated brain metastases that are stable without steroids for at least 21 days.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Cannot have untreated or symptomatic brain metastases.
- Cannot have had topotecan before.
- Cannot have had chemotherapy or radiotherapy within 3 weeks before starting the study.
- Cannot have unresolved side effects from previous cancer treatments.
- Cannot be taking other investigational drugs.
- Cannot have allergies to similar drugs used in the study.
- Cannot be taking certain medications that interact with M6620.
- Cannot have uncontrolled illnesses or psychiatric conditions that affect study participation.
- Cannot be pregnant or breastfeeding.
- Cannot have high-grade neuroendocrine cancers without small cell features.
- Cannot have Li-Fraumeni syndrome.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| University of Kansas Clinical Research Center | 66205 | Fairway | Kansas |
| HaysMed | 67601 | Hays | Kansas |
| University of Kansas Cancer Center | 66160 | Kansas City | Kansas |
| Lawrence Memorial Hospital | 66044 | Lawrence | Kansas |
| The University of Kansas Cancer Center - Olathe | 66061 | Olathe | Kansas |
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