Palbociclib for Brain Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Dana Farber Cancer Institute, Boston, MA
Brain Cancer+3 More
Palbociclib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Brain Cancer

Study Summary

Palbociclib In Progressive Brain Metastases

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Eligible Conditions

  • Brain Cancer
  • Brain Neoplasms
  • Cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Metastatic Malignant Neoplasm to Brain

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Palbociclib will improve 1 primary outcome and 5 secondary outcomes in patients with Brain Cancer. Measurement will happen over the course of 8 Weeks.

24 months
Number of Participants with Grade 3 or more hematologic toxicity; grade 3 or more neurologic toxicity
8 Weeks
Clinical Benefit Rate (Extracranial)
Clinical Benefit Rate (Intracranial)
Year 2
Extracranial disease progression rate
Intracranial disease progression rate
Year 2
Overall Survival Rate

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Side Effects for

Palbociclib With Adjuvant Endocrine Therapy
Neutrophil count decreased
48%
Fatigue
36%
Anemia
26%
Edema limbs
6%
Palpitations
4%
Blood and lymphatic system disorders - Other, specify
2%
Tinnitus
2%
Chills
2%
Pain
2%
Localized edema
1%
Bronchial infection
1%
Alopecia
1%
Dyspepsia
1%
Vestibular disorder
1%
Ear and labyrinth disorders - Other, specify
1%
Dry skin
1%
Nausea
1%
Diarrhea
1%
Cardiac disorders - Other, specify
1%
Lymphocyte count decreased
1%
Mucositis oral
1%
Breast infection
1%
Soft tissue infection
1%
Hypertension
1%
Lymph node pain
1%
Chest pain - cardiac
1%
Sinus bradycardia
1%
Non-cardiac chest pain
1%
Vertigo
1%
Sinus tachycardia
1%
Ear pain
1%
Pain of skin
1%
Fever
1%
Flu like symptoms
1%
Skin infection
1%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02040857) in the Palbociclib With Adjuvant Endocrine Therapy ARM group. Side effects include: Neutrophil count decreased with 48%, Fatigue with 36%, Anemia with 26%, Edema limbs with 6%, Palpitations with 4%.

Trial Design

2 Treatment Groups

Control
Palbociclib

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Palbociclib 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 2 and have already been tested with other people.

Palbociclib
Drug
Description Patients who fulfill eligibility criteria will be entered into the trial to receive Palbociclib After the screening procedures confirm participation in the research study: Palbociclib- Fixed Dose, daily for 21 days per cycle. The participant will be requested to maintain a medication diary of each dose of medication. The medication diary will be returned to clinic staff at the end of each cycle.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time from registration to the earlier of progression or death due to any cause. patients will be followed for a maximum of 2 years after end-of-treatment visit.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly time from registration to the earlier of progression or death due to any cause. patients will be followed for a maximum of 2 years after end-of-treatment visit. for reporting.

Who is running the study

Principal Investigator
P. B.
Priscilla Brastianos, Principal Investigator
Massachusetts General Hospital

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Brain Cancer or one of the other 3 conditions 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:
People who have had WBRT or SRS in the past are eligible for this study, as long as there is unequivocal evidence that one of the lesions treated by radiation has progressed (e.g show original
The patient has an ECOG performance status of ≤2, meaning they have a good prognosis and can carry out most everyday activities. show original
leukocytes ≥3,000/mcL
A blood test result of "absolute neutrophil count ≥1,500/mcL" suggests that a person has a high risk of infection. show original
platelets ≥100,000/mcL
To be eligible for the study, participants must have a solid tumor that has been confirmed by histology or cytology show original
Patients may have multiple lesions in their CNS, some of which may be treated by surgery or SRS show original
Some patients have lesions that remain after surgery, while others experience their lesions worsening after surgery. show original
Patients who have had systemic therapy for their CNS metastases in the past are eligible for the study. show original
There is no information on the toxicity of palbociclib in children aged ≥ 18 years. show original

Patient Q&A Section

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

How many people get brain cancer a year in the United States?

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Approximately 9.3 million new cases of brain cancer will occur in the United States in 2004. Of this, 4.1 million will occur in men and 4.1 million will occur in women. The number of people who develop brain cancer during their lifetime is estimated at 420,000.

Unverified Answer

What are common treatments for brain cancer?

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Only a short list of treatment options are commonly used for brain cancers, but treatment depends heavily on the type of tumor, how fast it has grown, and how quickly it is detected.\n

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What causes brain cancer?

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In this large database, risk factors for brain cancer include stroke, head injury, and smoking. Although the number of cases is small, the data indicate possible trends in the increasing number of brain cancer cases in this country.

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What are the signs of brain cancer?

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Most of the symptoms may be caused by a stroke, migraine, and intracranial tumour. Thus, brain imaging and thorough neurological and neuropsychiatric investigations may be helpful in differential diagnosis. However, most of the symptoms are nonspecific and may be associated with other diseases like brain abscess, intracranial haematoma or other intracranial tumours.

Unverified Answer

What is brain cancer?

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A large number of cancer survivors (approximately 30%) may have a brain tumour, yet nearly half (43%) of these patients will not be referred to an oncologist. If left untreated, brain cancer is a serious cause of pain and disability. Brain cancer patients often present with severe, distressing symptoms which frequently occur in patients with other serious conditions and that are difficult to manage adequately. Thus, patients presenting with brain cancer can benefit from multidisciplinary teams.

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Can brain cancer be cured?

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Brain cancer is almost always lethal and can be cured only with surgery. However, in selected individuals surgery has high cure rates in the longer term.

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Have there been any new discoveries for treating brain cancer?

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No new therapeutic approaches for treating tumors of the brain have been found up until today, so it is yet unknown what new possibilities exist for treatments of [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer). Brain tumors are often metastatic, so the treatment of the primary tumor is not possible. Most patients suffering from brain cancer are in the terminal stage of the disease. However, some new treatments may become available sooner and thereby prolong life. At least one promising therapy has been tested in patients with glioblastoma, as this type of cancer is the most advanced. It was found that patients suffering from brain cancer can live a month longer while on treatment. This treatment, called temozolomide, has been found more effective than treatment with corticosteroids.

Unverified Answer

How serious can brain cancer be?

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While the symptoms may vary depending on the cancer type, some brain tumors can cause a patient to become inactive, anxious, irritable or even comatose. This will impact on many people adversely. Also, brain tumors can have a negative effect on an individual’s mental faculties, as well as the cognitive abilities of the patient. Even though tumors may have a negative impact on a patient's ability to cope, it is important to understand that it can be possible to overcome an advanced stage brain tumor. With the correct treatments and a positive attitude towards life, an individual can overcome severe negative consequences. It remains the individual’s life and future. It is vital for a proper treatment and medical diagnosis to be taken.

Unverified Answer

What is the average age someone gets brain cancer?

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For men and women who had been diagnosed with [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer), the mean age of first diagnosis was 74.3 and 71.5 years, respectively. Among both men and women, however, a greater proportion of younger patients were diagnosed with brain cancer versus cancer elsewhere in the head and neck. The proportion of younger patients with brain cancer increased steadily from 1983 through 2001. In 1991, more than 30% of the patients diagnosed with brain cancer were less than 50 years old. More than half of the patients who had brain cancer were diagnosed between 70 and 79 years of age. Most patients with brain cancer who were diagnosed between the 50s and 60s were not under 60 years old.

Unverified Answer

What is the latest research for brain cancer?

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There is no good evidence for the superiority of any therapy for relieving symptoms. However, some drugs may produce slight improvements in function. Treatment for [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) is extremely difficult to standardise, and there is no good evidence of which treatment is best for everybody. There are several well-studied drugs and treatments for advanced cancer. A survey of current research indicates there are no high-quality studies on which treatment is preferable for every type of brain tumour. There is good evidence that chemotherapy is useful in relieving some symptoms. Surgery may help to improve symptoms for patients with a small tumour, but for most adults, surgery alone was not an effective symptom-relief treatment.

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What is the primary cause of brain cancer?

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This research presents the possibility that our current understanding of brain cancer may be flawed and lead us to overemphasize the role of genetics, as well as the role of exposure. These facts highlight the need for new methods of researching, and possibly treating, brain cancer..

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What does palbociclib usually treat?

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It is estimated that 50 to 70% of breast cancer patients have alterations of the ER-1/estrogen receptor pathway as well as a subset of high-grade, ER-/PT-negative metastatic breast cancer patients. These patients are not typically candidates to receive standard endocrine therapy but are often treated with palbociclib. Data from a recent study demonstrates that in nearly all patients treated with palbociclib, the drug is very effective at controlling estrogen receptor-positive, ER- tumors but does not seem to have an obvious effect in ER-/PT- tumors.

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