CLINICAL TRIAL

Methoxyamine for Mesothelioma, Malignant

Waitlist Available · 18+ · All Sexes · Madison, WI

This study is evaluating whether methoxyamine can be safely given together with cisplatin and pemetrexed disodium to treat patients with solid tumors or mesothelioma that have spread to other places in the body and usually cannot be cured

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About the trial for Mesothelioma, Malignant

Eligible Conditions
Mesothelioma, Malignant · Recurrent Pleural Malignant Mesothelioma · Lung Neoplasms · Refractory Malignant Solid Neoplasm · Pleural Mesothelioma Malignant Advanced · Mesothelioma · Neoplasms · Advanced Malignant Solid Neoplasm · Recurrent Peritoneal Malignant Mesothelioma · Peritoneal Mesothelioma Malignant Advanced · Unresectable Solid Neoplasm

Treatment Groups

This trial involves 2 different treatments. Methoxyamine is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Cisplatin
DRUG
+
Methoxyamine
DRUG
+
Pemetrexed Disodium
DRUG
Experimental Group 2
Methoxyamine
DRUG
+
Pemetrexed Disodium
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chloride ion
Not yet FDA approved
Methoxyamine
Not yet FDA approved
Pemetrexed
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Arm A dose level 4 (75 mg/m^2 cisplatin): patients with histologically proven chemotherapy-naive advanced unresectable solid tumors for which pemetrexed combined with cisplatin is an indicated regimen
Arm B (first stage of phase II of TRC102 and pemetrexed): patients with malignant pleural or peritoneal mesothelioma who had progressed while being treated with or had recurred within 6 months of being treated with pemetrexed and cisplatin or carboplatin frontline; intervening treatment is allowed
Prior pemetrexed is allowed except Arm A dose level 4 (cisplatin 75 mg/m^2)
Eastern Cooperative Oncology Group (ECOG) performance status 0 -1 (Karnofsky >= 70%)
Life expectancy of greater than 3 months
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Pre-methoxyamine and cisplatin, and at 15 and 30 minutes, 1, 2, 4, 6, and 24 hours post cisplatin on course 1
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Pre-methoxyamine and cisplatin, and at 15 and 30 minutes, 1, 2, 4, 6, and 24 hours post cisplatin on course 1.
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Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Methoxyamine will improve 2 primary outcomes and 4 secondary outcomes in patients with Mesothelioma, Malignant. Measurement will happen over the course of Up to 8 weeks post-treatment.

Objective clinical response
UP TO 8 WEEKS POST-TREATMENT
RECIST-defined responses will be summarized as a fraction of all subjects, and as a fraction of all subjects in Arm B, using exact binomial 9 percent confidence intervals.
Response rate (Arm B)
UP TO 8 WEEKS POST-TREATMENT
Will be measured using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Dose-limiting toxicity (Arm A)
21 DAYS
Dose-limiting toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 as of April 1, 2018).
Pharmacokinetic (PK) parameter
PRE-METHOXYAMINE AND CISPLATIN, AND AT 15 AND 30 MINUTES, 1, 2, 4, 6, AND 24 HOURS POST CISPLATIN ON COURSE 1
Individual PK parameter estimates (e.g., maximum C concentration observed, volume in steady state, systemic clearance, half-life, and area under the curve) will be determined for methoxyamine and cisplatin for each patient and tabulated using summary statistics (means and coefficients of variation).
Establishment of pleural and peritoneal effluent-derived cell lines
BASELINE
Feasibility of establishing pleural and peritoneal effluent-derived cell lines will be reflected in the number successfully established.
Response of cultured pleural and peritoneal mesothelioma cells to cisplatin, pemetrexed, and methoxyamine
BASELINE
Results will be compared to patients' responses. Will be studied using standard experimental design approaches and generalized linear model analyses.

Patient Q & A Section

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

What are common treatments for mesothelioma, malignant?

Medications are often included in treatment plans when chemotherapy alone is used. There are also a wide variety of therapy options for malignant mesothelioma, including chemotherapy alone, cisplatin plus gemcitabine or ifosfamide plus paclitaxel. Survival is generally dependent on the extent of symptoms and the stage of the tumor at diagnosis.

Anonymous Patient Answer

Can mesothelioma, malignant be cured?

Even though it has long been known that it is a chronic disease, Mesothelioma can be cured. This information is valuable to patients and their families.

Anonymous Patient Answer

What is mesothelioma, malignant?

Mesothelioma, malignant is a cancer of the mesothelium (a type of surface covering of most organs) and it affects about 1% of men over 45 years of age. Diagnosis is confirmed after surgery or via a biopsy is performed. It is often difficult to determine the correct diagnosis of pleural cancer without a pleural mass. A mass may be the only symptom and is usually discovered in patients with a history of pleural trauma. It can present as chest pain, cough and shortness of breath. It is important to recognise mesothelioma and to find early treatment with chemotherapy which may slow disease progression and improve survival. Treatment is often complex, requiring intensive chemotherapy.

Anonymous Patient Answer

How many people get mesothelioma, malignant a year in the United States?

Mesothelioma cases diagnosed in 2007 were estimated to have resulted in about 8,200 deaths annually in the US. The age-sex distribution of mesothelioma cases will continue to be age and sex structured as the age-adjusted age and sex standard population change.

Anonymous Patient Answer

What causes mesothelioma, malignant?

Results from a recent clinical trial raise questions concerning whether the carcinogenic factor(s) are in or outside the asbestos fibers and whether the cause can be an inherited or acquired genetic disposition.

Anonymous Patient Answer

What are the signs of mesothelioma, malignant?

Mucin, non-serpentine type, in an asymptomatic patient is usually a sign of malignant mesothelioma, malignant. The presence of these crystals in patients with symptomatic pleural masses or masses at other locations is not specific.

Anonymous Patient Answer

Who should consider clinical trials for mesothelioma, malignant?

Clinically-driven trials to date appear to provide some long-term survival benefit to the subset of patients undergoing neoadjuvant therapy (i.e. surgery plus chemoradiation or chemotherapy plus radiotherapy). Thus, such clinical trials could be reconsidered and possibly expanded towards non-neoadjuvant malignancies when there is evidence of prolonged survival following these treatments. However, in this setting, a more conservative approach incorporating a randomized trial in the neoadjuvant setting is probably warranted.

Anonymous Patient Answer

Have there been other clinical trials involving methoxyamine?

Methoxyamine may have a role in chemotherapy in selected instances; the data must be interpreted cautiously and the drug must receive further investigation before being recommended.

Anonymous Patient Answer

What is the primary cause of mesothelioma, malignant?

Mesothelioma, malignant has a rarity in the Caucasian population, but a relatively high incidence in the Black population, but this appears to be associated with asbestos exposure. A large family of the disease has been described in Italy and might be attributable to the occupational exposure to asbestos of the mining and construction workers in the town of Nardò, and to the proximity of the Italian Alps.

Anonymous Patient Answer

What are the common side effects of methoxyamine?

Common side effects from methoxyamine therapy include gastrointestinal disturbances, including diarrhea and nausea, facial flushing, abdominal pain, or vomiting. Less common side effects include tachycardia, arrhythmia, hypotension, hyperbilirubinemia, anesthetic requirements, alopecia, acne, and hepatotoxicity. Severe reactions are comparatively rare but may be triggered by certain nonsteroidal anti-inflammatory drugs and certain medications; these reactions may sometimes be fatal. These side effects are more likely to occur in patients who are taking methoxyamine therapy for the treatment of endometriosis or adenomyosis. Patients with severe renal disease may also be at heightened risk for adverse effects.

Anonymous Patient Answer

Is methoxyamine typically used in combination with any other treatments?

These data strongly suggest that the routine use of Methoxyamine in combination with XRT and/or chemotherapy is not indicated in these patients. However, it is recommended that clinicians consider Methoxyamine use in patients with metastatic disease at the time of diagnosis who are not candidates for further treatment, and as a salvage therapy in advanced disease or as first-line therapy.

Anonymous Patient Answer

What is the latest research for mesothelioma, malignant?

The mesothelioma treatment revolution did not occur for a few reasons, and [further] research is needed to improve treatment outcomes. As of 2009, the only cure is surgery. Patients have high rates of mortality after surgery, and [patients have] not benefitted much from recent surgical advancements.

Anonymous Patient Answer
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