CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma
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|ClinicalTrials.gov Identifier: NCT03727789|
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cutaneous Melanoma of the Extremity Advanced Sarcoma of the Extremity Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Pathologic Stage IV Cutaneous Melanoma AJCC v8 Recurrent Cutaneous Melanoma of the Extremity Recurrent Sarcoma of the Extremity Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8||Drug: FACT Complex-targeting Curaxin CBL0137||Phase 1|
I. To estimate the maximum tolerated dose (MTD) and examine the dose-limiting toxicities of intra-arterial facilitates chromatin transcription (FACT) complex-targeting curaxin CBL0137 (CBL0137) in patients with advanced extremity melanoma or sarcoma.
I. To assess the tumor response in advanced melanoma and sarcoma patients treated with intra-arterial administration of CBL0137.
II. To define both response in-field (area of the limb distal to the infusion point) and out-of-field (any area proximal to the infusion point) in patients treated with CBL0137 based intra-arterial infusion.
III. Assess the pharmacokinetics of CBL0137 in the study population pre-and post CBL0137 intraarterial infusion.
IV. Assess tumor protein expression profiles before and after treatment with CBL0137.
I. To assess if the proposed treatment has any effect on quality of life as measured by the Functional Assessment of Cancer Therapy ? Melanoma (assessment tool also applicable to sarcoma).
OUTLINE: This is a dose-escalation study of FACT complex-targeting curaxin CBL0137.
Patients receive FACT complex-targeting curaxin CBL0137 intra-arterially (IA) over 15 minutes.
After completion of study treatment, patients are followed up at 2, 6 and 12 weeks, every 3 months for 12 months, then at 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Center Phase I Dose Escalation/Response Trial to Evaluate Safety, Tolerability, and Anti-Tumor Efficacy of Intra-Arterial CBL0137 for Patients With Advanced Extremity Melanoma or Sarcoma|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||August 8, 2021|
|Estimated Study Completion Date :||August 8, 2022|
Experimental: Treatment (CBL0137)
Patients receive FACT complex-targeting curaxin CBL0137 IA over 15 minutes.
Drug: FACT Complex-targeting Curaxin CBL0137
Other Name: CBL0137
- 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. [ Time Frame: Up to 24 months ]The frequency of toxicities will be tabulated by grade across all dose levels. The frequency of toxicities will also be tabulated for the dose estimated to be the maximum tolerated dose.
- Tumor response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 modified for cutaneous, out-of-field, and deeper lesions [ Time Frame: Up to 24 months ]Responses will be tabulated, and complete response rate will be estimated with its exact 80% confidence interval.
- Duration of tumor response (both in the field of infusion therapy and out-of-field) assessed by RECIST 1.1 [ Time Frame: Up to 24 months ]
- Duration of regional progression free survival (PFS) assessed by RECIST 1.1 [ Time Frame: Up to 24 months ]
- Overall PFS assessed by RECIST 1.1 [ Time Frame: Up to 24 months ]
- Incidence and type of adverse events assessed using NCI CTCAE v.5 [ Time Frame: Up to 24 months ]
- Incidence of Adverse Events [ Time Frame: Baseline up to 24 months ]Changes in clinical laboratory values while receiving CBL0137
- Incidence of Adverse events [ Time Frame: At pre- and post-intraarterial infusion assessed up to 24 months ]Drug safety
- Tumor levels of p53^Ser392 and HSP70 assessed by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Up to 24 months ]
- Quality of life (QOL) measured using the Functional Assessment of Cancer Therapy - Melanoma (FACT-M v.4) and the associated Melanoma Cancer subscale (MCS) [ Time Frame: Up to 24 months ]Median and range baseline subscale and total QOL scores, as well as single item scores, will be presented, followed by mean change scores for subscales, the total scale and single items, compared between different study intervention groups.
- Quality of life (QOL) measured using the associated Melanoma Cancer subscale (MCS) [ Time Frame: Up to 24 months ]Median and range baseline subscale and total QOL scores, as well as single item scores, will be presented, followed by mean change scores for subscales, the total scale and single items, compared between different study intervention groups.
- Melanoma-related symptoms measured using the FACT-M v.4 [ Time Frame: Up to 24 months ]
- Melanoma-related symptoms measured using the associated Melanoma Cancer Subscale [ Time Frame: up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727789
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Joseph J. Skitzki 716-845-1212 Joseph.Skitzki@roswellpark.org|
|Principal Investigator: Joseph J. Skitzki|
|Principal Investigator:||Joseph Skitzki||Roswell Park Cancer Institute|