Oral Decitabine for Head and Neck Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Head and Neck Cancer+1 More
Oral Decitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients

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Eligible Conditions

  • Head and Neck Cancer

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Oral Decitabine will improve 2 primary outcomes and 3 secondary outcomes in patients with Head and Neck Cancer. Measurement will happen over the course of 2 months.

2 months
Phase I: Biologically Effective Dose (BED) of oral decitabine (ASTX 727)
2 years
Phase I: Number of participants with treatment-related adverse events
Phase II: Best overall objective response rate (ORR)
Phase II: Overall survival (OS)
Phase II: Progression free survival (PFS)

Trial Safety

Trial Design

1 Treatment Group

Oral Decitabine and Durvalumab
1 of 1
Experimental Treatment

This trial requires 13 total participants across 1 different treatment group

This trial involves a single treatment. Oral Decitabine 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.

Oral Decitabine and DurvalumabOral decitabine (ASTX 727) will be administered alone in Cycle 1 and the combination of oral decitabine and durvalumab therapy will be given in Cycles 2-12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
S. P.
Sara Pai,, MD PhD
Massachusetts General Hospital

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Head and Neck Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Written informed consent and any locally-required authorization (e.g., HIPAA in the UEU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Age ≥ 18 years at time of study entry or adult male or female (according to age of majority as defined as ≥18 years)
Histologically confirmed recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Patients who refuse radical resection are eligible.
Tumor progression or recurrence during or after treatment with anti-PD1, anti-PDL1, anti-PDL2, anti-CTLA4, or other immune checkpoint inhibitor where the most recent dose was given within 3 months prior to study registration.
Must give valid written consent to provide archival FFPE and/or newly acquired tumor tissue for the purpose of establishing baseline PD-L1 status as well as consent to provide on- and/or post-treatment tumor biopsy sample.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
Life expectancy of > 6 months
At least 1 lesion that can be accurately measured at baseline as > 10 mm in the longest diameter (except lymph nodes which must have a short axis >15 mm) with CT or MRI and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines.
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3)

Patient Q&A Section

What causes head neoplasms?

"It was not possible to pinpoint all factors that contributed to the development of head neoplasms. These tumors were mainly benign and the most frequent tumors were the intracranial ependymomas and benign meningiomas. The majority of ependymomas are considered high grade, in the majority of benign meningiomas, and in the majority of malignant meningiomas." - Anonymous Online Contributor

Unverified Answer

How many people get head neoplasms a year in the United States?

"This is the first study of the number of individuals with head neoplasms, diagnosed by ICD-O-2, among those 40 years of age or older in the United States. These data will be useful for evaluating the need for a national screening program, and for assessing the number of head neoplasms and type of cancer among the elderly." - Anonymous Online Contributor

Unverified Answer

Can head neoplasms be cured?

"The chances that head neoplasms can be cured are very slim. Patients or their families should be informed of this fact and discuss the various options for treatment before considering treatment." - Anonymous Online Contributor

Unverified Answer

What is head neoplasms?

"Head neoplasms encompass a spectrum of tumor growth patterns with well-defined histologies. The treatment for the vast majority of cases involves surgical resection, but adjuvant systemic and radiofrequency ablation are increasingly used to augment or complement surgery." - Anonymous Online Contributor

Unverified Answer

What are common treatments for head neoplasms?

"The treatment of choice for children and adolescents with head neoplasm depends on the presentation of each patient and the degree of tumor progression. Surgery is often combined with chemotherapy or radiation therapy, depending on the location and stage of disease. Chemotherapy is the standard treatment for most medulloblastoma, and cranial irradiation is commonly used to prevent relapse for advanced disease. There is a debate whether chemotherapy improves outcome. A multidisciplinary approach is often needed to optimize treatment. Surgical resection may be combined with radiotherapy and chemotherapy, and in selected patients with good performance or low neuroblastic profile, surgical removal may be curative." - Anonymous Online Contributor

Unverified Answer

What are the signs of head neoplasms?

"In most of the cases, the mainstay of diagnosis is the clinical examination. Imaging studies may also be needed. The presence of visual proclinic signs and/or neurologic symptoms indicates a CNS malignancy. In the remainder, a thorough head, neck, chest and abdominal examination is required for an accurate diagnosis. Other signs of head neoplasms include headache, seizure-like activity, paresthesias and visual field deficits. The diagnosis of brain tumor and its location is particularly challenging in those with concomitant intrathecal or epidural extension." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing head neoplasms?

"[5 year survival for patients with and without head neoplasms was 77.8% and 53.8% respectively. Patients with head neoplasia have a 2.3 fold increased likelihood of developing brain or sinus tumors (95% C.I: 1.1% to 10.7%) as well as a 4.5 fold greater likelihood of developing a malignant central nervous system tumor after a year (95%C.I: 2.5 to 8.6).] The higher the degree of atrophy assessed on T1- and T2-weighted images, the higher the risk of developing a malignant lesion." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for head neoplasms?

"Clinical trials for head neoplasms seem to be an interesting treatment option for head neoplasms that is appropriate for all patients, considering their willingness to accept the risk (and the possibility of benefiting from the treatment), as well as their social, financial, and emotional situations at that moment in their live cycles. Clinicaltrial.gov is not a cure for treatment-resistant brain neoplasms, but it is a way to find and obtain more effective and affordable therapies." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of head neoplasms?

"Primary head neoplasms do not follow the classical aetiology, i.e., they have a multiple cause. The classical aetiology is applicable to only 25% of HNP, but in most cases this aetiology is present." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for head neoplasms?

"The survival rate of patients with head neoplasms is higher than most other cancers. Brain metastases have the highest risk of metastasizing and spread to other solid organs after the diagnosis of primary tumors, and are therefore the most likely cause for death in these patients. More studies need to be done to predict the prognosis in each type of metastatic lesions. Patients with liver metastases are particularly difficult to treat and survive, but can be cured by surgical removal when possible." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in oral decitabine for therapeutic use?

"The new oral decitabine is a safe and effective treatment for children with high-risk ALL. It is likely to be an alternative to the commonly prescribed conventional (intramuscular) schedule where there may be a risk of intramuscular administration-site reactions." - Anonymous Online Contributor

Unverified Answer

What is the latest research for head neoplasms?

"The head neoplasms are becoming more and more difficult to treat with traditional therapies. There is still not a definitive, evidence-based treatment. We are going to need to revisit the research that we have done, so that we can get a better understanding of tumors and how we treat them." - 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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