Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03730363
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2018-10-26
Brief Title:
Pentamidine Salvage Chemo for RelapsedRefractory Classical Hodgkin Lymphoma
Sponsor:
Reinhold Munker
Organization:
University of Kentucky
Study Overview
Official Title:
A Phase I Study of Pentamidine in Combination With Salvage Chemotherapy for RelapsedRefractory Classical Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
To evaluate dose limiting toxicity and to determine the recommended phase 2 dose RP2D of pentamidine in combination with salvage chemotherapy with ifosfamide carboplatin and etoposide ICE on a 3-weeks schedule in relapsedrefractory classical Hodgkin lymphoma cHL
Secondary Objective
To estimate the overall best treatment response at 5- and 16-weeks from study enrollment Although the clinical benefit of these drugs in combination has not been established offering this treatment may provide a therapeutic benefit The patients will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability
To estimate the duration of response to the proposed combined therapy
To measure the protein of regenerating liver-3 PRL-3 level of expression in patients at time of relapse
To measure circulating biomarkers of response soluble CD30 sCD30 and thymus and activation-related chemokine TARC in serum samples collected throughout treatment and inhibition of pSTAT pAKT in peripheral blood mononucleated cells PBMC
Exploratory Objective
To measure cell-free messenger RNA cfmRNA in peripheral blood
To measure cell-free DNA in peripheral blood
To evaluate dose limiting toxicity and to determine the recommended phase 2 dose RP2D of pentamidine in combination with salvage chemotherapy with ifosfamide carboplatin and etoposide ICE on a 3-weeks schedule in relapsedrefractory classical Hodgkin lymphoma cHL
Secondary Objective
To estimate the overall best treatment response at 5- and 16-weeks from study enrollment Although the clinical benefit of these drugs in combination has not been established offering this treatment may provide a therapeutic benefit The patients will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability
To estimate the duration of response to the proposed combined therapy
To measure the protein of regenerating liver-3 PRL-3 level of expression in patients at time of relapse
To measure circulating biomarkers of response soluble CD30 sCD30 and thymus and activation-related chemokine TARC in serum samples collected throughout treatment and inhibition of pSTAT pAKT in peripheral blood mononucleated cells PBMC
Exploratory Objective
To measure cell-free messenger RNA cfmRNA in peripheral blood
To measure cell-free DNA in peripheral blood
Detailed Description:
The primary objective of this Phase I study is to determine the maximum tolerated dose MTD of Pentamidine A two-stage continual reassessment method CRM will be employed to determine dose escalation levels and the maximum tolerated dose MTD of Pentamidine
Specifically a modified two-stage CRM will be employed with 2 patients per cohort at each dose level The trial starts with an escalation design from the lowest dose 2 mgkg with a traditional 22 dose escalation method After occurrence of the first DLT dose assignment will be determined by the CRM 2 patientsper cohort using empirical model with restrictions to avoid dose-skipping and escalation immediately after a toxicity outcome
A maximum of 12 patients will be enrolled into the trial during the escalation phase Once the MTD is reached an additional 4 patients will be treated at this dose Thus 6 or more patients will be treated at the MTD
The target DLT rate is 33 and the investigators choose to use 010 020 and 033 as prior toxicity distribution CRM simulations indicate optimal performance of this design with high dose recommendation probabilities at least 48 and more patients allocated to the correct dose
Specifically a modified two-stage CRM will be employed with 2 patients per cohort at each dose level The trial starts with an escalation design from the lowest dose 2 mgkg with a traditional 22 dose escalation method After occurrence of the first DLT dose assignment will be determined by the CRM 2 patientsper cohort using empirical model with restrictions to avoid dose-skipping and escalation immediately after a toxicity outcome
A maximum of 12 patients will be enrolled into the trial during the escalation phase Once the MTD is reached an additional 4 patients will be treated at this dose Thus 6 or more patients will be treated at the MTD
The target DLT rate is 33 and the investigators choose to use 010 020 and 033 as prior toxicity distribution CRM simulations indicate optimal performance of this design with high dose recommendation probabilities at least 48 and more patients allocated to the correct dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None