CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma (NCT03727789) | Clinical Trial Compass
TerminatedPhase 1
CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma
Stopped: low accrual
United States7 participantsStarted 2019-07-01
Plain-language summary
This phase I trial studies best dose and side effects of CBL0137 in treating patients with extremity melanoma or sarcoma that has spread to other places in the body. Drugs, such as CBL0137, may work by binding to tumor cell deoxyribonucleic acid (DNA) to stop the cell from growing further.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must have a life expectancy of \> 6 months.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
* Patients either:
* Must not have undergone any limb-directed treatment OR
* Have undergone a previous Melphalan based regional therapy for which they did not have a complete response and, present with persistent, progressive, or recurrent disease.
* \* NOTE: Patients with indeterminate staging must be reviewed by the Principal Investigator prior to registration.
* Patient must have had a washout period for at least 30 days or 5 half-lives from any prior chemotherapy, radioactive, or hormonal cancer therapy, or 4 weeks from any checkpoint inhibitors or other biologic (including TVEC), whichever is longer
* Patient must have histologically proven primary or recurrent extremity melanoma (stage IIIB, IIIC, or IV), or advanced extremity sarcoma not amenable to surgical resection
* (American Joint Committee on Cancer \[AJCC\] melanoma staging must be documented in patient's medical record, as determined by computed tomography \[CT\] of the chest, abdomen and pelvis, within six weeks prior to administration of study drug;
* Due to the heterogeneous nature of sarcoma, AJCC sarcoma staging is NOT required
* Patients with Stage IIIC disease must either have had regional lymph nodes previously removed or have stable or regressed disease on imaging from prior systemic therapy (defined as modified RECIST 1.1 SD, CR, or PR).
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What they're measuring
1
Dose-limiting toxicities (DLTs) defined based on the rate of drug-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (CTCAE) (v.) 5.