Palbociclib In Progressive Brain Metastases

  • STATUS
    Recruiting
  • End date
    Sep 25, 2024
  • participants needed
    30
  • sponsor
    Massachusetts General Hospital
Updated on 25 January 2021

Summary

This research study is studying palbociclib as a possible treatment for recurrent brain metastases.

  • Pfizer, a pharmaceutical company, is supporting this research study by providing the study drug as well as funding for research activities

Description

  • This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
    • This is a study designed to evaluate the efficacy and safety of palbociclib in recurrent brain metastases. Palbociclib is being studied for use in the treatment of a broad range of cancers. This type of drug inhibits cell growth in the cells called cyclin-dependent kinases which promote tumor cell proliferation.
    • The FDA (the U.S. Food and Drug Administration) has not approved palbociclib for participants specific disease but it has been approved for other uses

Details
Condition Brain Metastasis, Brain Metastases, Metastatic Malignant Neoplasm to Brain
Treatment Palbociclib
Clinical Study IdentifierNCT02896335
SponsorMassachusetts General Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Metastatic Malignant Neoplasm to Brain?
Do you have any of these conditions: Brain Metastasis or Metastatic Malignant Neoplasm to Brain or Brain Metastases?
Participants must have histologically or cytologically confirmed disease from any solid tumor
Participants must have measurable disease in the CNS, defined as at least one lesion that can be accurately measured in at least one dimension as 10 mm
Participants must have progressive CNS lesions, as defined by one of the following
Patients may have multiple progressive CNS lesions, some of which have been treated by SRS or surgery. Patients are eligible if they have one or more un-treated (by surgery or SRS) progressive lesions that is measurable
Patients have measurable residual or progressive lesions after surgery
Patients who have had prior WBRT and/or SRS are eligible but there needs to be unequivocal evidence of progression of at least one lesion treated by radiation (e.g. tissue diagnosis). Biopsy can be considered for definitive diagnosis
Patients who have previously been treated with systemic therapy for CNS metastases are eligible
Age 18 years. The toxicity of palbociclib in children is unknown
ECOG performance status 2 (Karnofsky 60%, see Appendix A)
Participants must have normal organ and marrow function as defined below
leukocytes 3,000/mcL
absolute neutrophil count 1,500/mcL
platelets 100,000/mcL
hemoglobin >9g/dL
total bilirubin 1.5 x institutional upper limit of normal
\--- OR
> 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range
AST(SGOT)/ALT(SGPT) 2.5 institutional upper limit of normal
creatinine within normal institutional limits
\--- OR
creatinine clearance 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
baseline QTc <480ms
The effects of palbociclib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of palbociclib administration
Ability to understand and the willingness to sign a written informed consent document
Tissue from a prior craniotomy or biopsy for genetic sequencing (at least one FFPE block or 15 unstained slides). Patients previously assessed for genetic sequencing who meet requirements of section 9.2.1 do not need to have additional tissue available for prospective genetic sequencing
Presence of alteration in CDK pathway (amplifications in CDK4, CDK6, CCND1, CCND2, CCND3 or CCNE1 or loss of CDKN2A)
Patients with progressive extracranial disease will not be excluded
Stable corticosteroids for at least 7 days

Exclusion Criteria

Prior treatment with CDK4/6 inhibitor
Participants who have had chemotherapy, immunotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier
Participants who are receiving any other investigational agents
Participants who are receiving other concurrent chemotherapies or immunotherapies for their cancer (except for patients who will receive letrozole, anastrozole, exemestane, tamoxifen, fulvestrant, trastuzumab, bisphosphonates, or ovarian suppression therapy)
Leptomeningeal involvement of cancer
History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib (including abemaciclib)
Participants receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A isoenzymes are ineligible. Lists including medications and substances known or with the potential to interact with the CYP3A isoenzymes are provided in Appendix C, and can also be found within section 5.4. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as <http://medicine.iupui.edu/clinpharm/ddis/table.aspx>; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with palbociclib, breastfeeding should be discontinued if the mother is treated with palbociclib
HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with palbociclib. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated
Current use of drugs that are known to prolong the QT interval (See Appendix C)
Unable to undergo MRI scans
QTc>480 msec (based on the mean value of the triplicate ECGs), family or personal history of long or short QTc prolongation, or Torsade de Pointes (TdP)
Uncontrolled electrolyte disorders that can compound the effects of QTc-prolonging drug (eg. hypocalcemia, hypokalemia, hypomagnesemia
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