Positron Emission Tomography for Metastatic NUT Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana-Farber - Harvard Cancer Center LAO, Boston, MA
Metastatic NUT Carcinoma+3 More
Positron Emission Tomography - Procedure
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

Testing the Safety and Efficacy of the Addition of A New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Etoposide and Cisplatin) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma

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Eligible Conditions

  • Metastatic NUT Carcinoma
  • Advanced NUT Carcinoma
  • Unresectable NUT Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metastatic NUT Carcinoma

Study Objectives

This trial is evaluating whether Positron Emission Tomography will improve 2 primary outcomes and 13 secondary outcomes in patients with Metastatic NUT Carcinoma. Measurement will happen over the course of Up to 21 days of each cycle.

Year 2
Pharmacodynamic parameters (phase 1, phase 2, and non-thoracic, non-BRD4 exploratory cohorts)
Pharmacodynamic parameters (phase 1, phase 2, non-thoracic, non-BRD4 exploratory cohorts)
Year 2
Progression-free survival (PFS) (phase 1 and 2)
Progression-free survival (PFS) (phase 1, phase 2, and non-thoracic, non-BRD4 exploratory cohort)
Year 2
Overall survival (OS) (phase 1 and 2)
Overall survival (OS) (phase 1, phase 2, and non-thoracic, non-BRD4 exploratory cohort)
Year 2
Duration of response (DoR) (phase 1 and 2)
Duration of response (DoR) (phase 1, phase 2, and non-thoracic, non-BRD4 exploratory cohort)
Up to 2 years
Incidence of adverse (phase 2)
Incidence of adverse events (phase 2)
ORR (phase 1 and non-thoracic, non-BRD4 exploratory cohort)
ORR (phase 1)
Objective response rate (ORR) in patients following treatment with triplet combination (phase 2)
The recommended phase 2 dose (RP2D) from phase 1 (phase 2)
Day 21
Maximum tolerated dose (MTD) (phase 1)

Trial Safety

Safety Progress

1 of 3

Other trials for Metastatic NUT Carcinoma

Trial Design

1 Treatment Group

Treatment (ZEN-3694, etoposide, cisplatin)
1 of 1
Experimental Treatment

This trial requires 55 total participants across 1 different treatment group

This trial involves a single treatment. Positron Emission Tomography is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Treatment (ZEN-3694, etoposide, cisplatin)Patients receive ZEN003694 PO QD on days 1-14 of each cycle or PO QD 5 days on, 2 days off over days 1-14 of each cycle depending on dosage. All patients may receive ZEN003694 PO QD on days 1-21 starting cycle 5 at the discretion of treating investigator. Patients also receive etoposide IV over 60 minutes on days 1-3 for cycles 1-4 or up to 8 cycles, and cisplatin IV over 60 minutes on day 1 of cycles 1-4 or up to 8 cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2019
Completed Phase 2
~3050
Computed Tomography
2017
Completed Phase 2
~3460
Biopsy
2011
Completed Phase 4
~1310
Chest Radiography
2018
N/A
~560
Magnetic Resonance Imaging
2017
Completed Phase 2
~1120
Chloride ion
Not yet FDA approved
Beta-D-Glucose
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Dana-Farber - Harvard Cancer Center LAO - Boston, MA

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants must have disease that is metastatic, unresectable, or for which a surgical approach would not likely confer a survival benefit or would be otherwise contraindicated. show original
PHASE 1, PHASE 2, AND NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Age >= 12 years. Patients 12-17 years of age must be >= 40 kg at enrollment. Because no dosing or adverse event data are currently available on the use of ZEN003694 in combination with etoposide and cisplatin in patients < 12 years of age, younger children are excluded from this study.
PHASE 1, PHASE 2, AND NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Eastern Cooperative Oncology Group performance status of =< 2 (Karnofsky >= 60%) for patients >= 16 years of age, Lansky >= 50% if < 16 years of age.
You have a tumor that is determined to be a NUT-positive tumor by IHC testing performed in a CLIA certified laboratory. show original
You have a NUT gene translocation as determined by FISH performed at the Bringham and Women's Hospital (BWH) Center for Advanced Molecular Diagnostics (CAMD). show original
PHASE 1, PHASE 2, AND NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Patients in the phase 1 portion do not need measurable disease if their disease is otherwise evaluable.
PHASE 1, PHASE 2, AND NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Ability to swallow and retain oral medications.
PHASE 1, PHASE 2, AND NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Absolute neutrophil count >= 1.5 x 10^9/L
PHASE 1, PHASE 2, AND NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Platelets >= 125 x 10^9/L
PHASE 1, PHASE 2, AND NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Hemoglobin >= 9.0 g/dL

Patient Q&A Section

What are the signs of carcinoma?

"Carcinoma is frequently asymptomatic. It rarely appears as a painless mass. It is more frequently a mass present on imaging studies. Pain is a common feature of carcinoma, but is also noted in a wide variety of diseases. Symptoms are not specific to any tumor. Patients with a history of skin cancer are at increased risk for developing squamous cell carcinoma of the oral cavity or other sites or are at greater risk for presenting with squamous cell carcinoma of the head and neck. Lymph node involvement increases the likelihood of oral squamous cell carcinoma. Squamous cell carcinoma of the head and neck is an absolute indication for mandibular or maxillary reconstruction." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma?

"This survey confirms the use of chemotherapy, surgical resection, and the use of radiation therapy for cancer patients within the last 12 months. However, the use of hormonal therapy for breast cancer patients during this time period has decreased, which leads us to propose that hormone-sensitive cancers are now being addressed with hormonal therapy." - Anonymous Online Contributor

Unverified Answer

What is carcinoma?

"Carcinoma is a disorder of uncontrolled cell growth of epithelial cell tumors. Carcinoma is the leading cause of cancer death in children and teenagers. Carcinoma accounts for about 80% of malignant neoplasm in the USA." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma a year in the United States?

"Cancer incidence in the US has increased since the mid-1990s. In addition, there are differences in cancer incidence between blacks and whites. The average age at diagnosis is late, as more people are surviving longer." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma?

"The evidence regarding the carcinogenic effects of dietary factors is fairly poor. However, dietary factors are commonly related to many cancers, and many cancers occur in an orderly sequence that suggests pathogenetic processes. It is conceivable that dietary factors play a part in the development of many cancers, perhaps acting via interaction with the environment as well as by direct influence on cells. Furthermore, the observation that many cancers are linked to smoking and alcohol drinking further suggests that exposures to carcinogenic substances are involved." - Anonymous Online Contributor

Unverified Answer

Can carcinoma be cured?

"Adenocarcinoma of the prostate is a rarity and metastasis is an exceedingly rare finding in prostate adenocarcinoma. Radical prostatectomy as well as external beam radiotherapy remains the best treatment options. To the authors' knowledge, only a few studies have addressed the topic of surgical salvage of localized recurrent disease or in combination with pelvic lymphadenectomy. Results from a recent clinical trial from this retrospective, single institution database case series reveal that patients with biochemical parameters of relapse can potentially be cured. These patients have demonstrated complete remissions with surgical salvage. Results from a recent clinical trial warrant further investigation to determine which patients will benefit from salvage surgery with concurrent or sequential pelvic lymphadenectomy." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma?

"As there have been advances in chemotherapy and radiation therapy in last decades, there have been few new discoveries for improving quality of life and survival for metastatic carcinoma patients. As we have no evidence from recent studies of improved survival and quality of life, we can only conclude that there is no new method to treat metastatic carcinoma patients." - Anonymous Online Contributor

Unverified Answer

Has cisplatin proven to be more effective than a placebo?

"This meta-analysis suggests that cisplatin is significantly more effective than a placebo with respect to tumour response rate and CRP clearance in patients diagnosed with advanced non-small-cell lung carcinoma or head and neck cancer who receive no prior chemotherapy." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma?

"The survival rate of patients with carcinoma is very low in the Korean population. The prognosis of cancer is significantly more poor than that of inpatient patients." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in cisplatin for therapeutic use?

"DDP continues to be a powerful treatment, with the potential to improve patient outcomes and help lower the burden of ovarian cancer. A careful balance of tumour response rate with patient risk factors must be considered. Further investigation is warranted into molecular effects and the potential to improve clinical trials evaluating DDP." - Anonymous Online Contributor

Unverified Answer

Is cisplatin safe for people?

"The use of the current high dose (80 mg/m2) of cisplatin is safe. The use of cisplatin infusion might not be necessary in children>16 years." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of cisplatin?

"Cisplatin is an effective anti-cancer drug, but it may present an increased risk of serious adverse events that sometimes require hospitalization or medical treatment. The most common adverse reactions were hemorrhagic cystitis and nephrotoxicity." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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