Low Dose Versus Standard Dose Dexamethasone for Reduction of Swelling in Patients With Primary or Metastatic Brain Tumors
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| ClinicalTrials.gov Identifier: NCT05139043 |
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Recruitment Status :
Recruiting
First Posted : December 1, 2021
Last Update Posted : August 5, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Brain Neoplasm Metastatic Malignant Neoplasm in the Brain Recurrent Malignant Brain Neoplasm | Drug: Dexamethasone | Phase 2 |
PRIMARY OBJECTIVES:
I. Assess the feasibility of administering lower doses of dexamethasone post-operatively in patients who have mild to moderate cerebral edema pre-operatively.
II. Describe the toxicity profile associated with post-operative lower doses and standard doses of dexamethasone, separately.
SECONDARY OBJECTIVES:
I. Descriptively assess the consistency between the quantitative data produced by strategically acquired gradient echo (STAGE) and qualitative assessments of changes in cerebral edema on serial fluid-attenuated inversion recovery (FLAIR) images.
II. Quantitatively assess changes in the volume of cerebral edema post-operatively in participants on Arm 1 (standard dose) and Arm 2 (low dose).
EXPLORATORY OBJECTIVE:
I. Describe changes in the volume of cerebral edema between pre-operative and post-operative day 1 brain magnetic resonance imaging (MRIs) in Arm 1 (standard dose) and Arm 2 (low dose) participants, separately.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard dose dexamethasone orally (PO) every 12 hours (q 12 h) for 3 days. On the day of surgery, patients receive standard dose dexamethasone intravenously (IV) before and after the surgery. Patients receive standard dose dexamethasone IV q 12 h on days 1-3 post surgery and tapered dexamethasone PO q 12 h on days 4-14 in the absence of disease progression or unacceptable toxicity. Additional doses of dexamethasone are given if needed.
ARM II: Patients receive lower dose dexamethasone PO q 12 h for 3 days. On the day of surgery, patients receive lower dose dexamethasone IV before and after the surgery. Patients receive lower dose dexamethasone IV q 12 h on days 1-3 post surgery and tapered dexamethasone PO q 12 h on days 4-14 in the absence of disease progression or unacceptable toxicity. Additional doses of dexamethasone are given if needed.
After completion of surgery, patients are followed up after 30 days.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Safety and Imaging of Post-Operative Low Dose Versus Standard Dose Dexamethasone in Patients With Primary or Metastatic Brain Tumors: a Randomized, Double-blinded Feasibility Study. |
| Actual Study Start Date : | April 9, 2022 |
| Estimated Primary Completion Date : | November 15, 2024 |
| Estimated Study Completion Date : | November 15, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm I (standard dose dexamethasone)
Patients receive standard dose dexamethasone PO q 12 h for 3 days. On the day of surgery, patients receive standard dose dexamethasone IV before and after the surgery. Patients receive standard dose dexamethasone IV q 12 h on days 1-3 post surgery and tapered dexamethasone PO q 12 h on days 4-14 in the absence of disease progression or unacceptable toxicity. Additional doses of dexamethasone are given if needed.
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Drug: Dexamethasone
Given IV and PO
Other Names:
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Experimental: Arm II (lower dose dexamethasone)
Patients receive lower dose dexamethasone PO q 12 h for 3 days. On the day of surgery, patients receive lower dose dexamethasone IV before and after the surgery. Patients receive lower dose dexamethasone IV q 12 h on days 1-3 post surgery and tapered dexamethasone PO q 12 h on days 4-14 in the absence of disease progression or unacceptable toxicity. Additional doses of dexamethasone are given if needed.
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Drug: Dexamethasone
Given IV and PO
Other Names:
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- Lack of feasibility [ Time Frame: Up to post-operative day 8 ]Defined as a participant requiring more than 18 mg of dexamethasone beyond the planned dose per treatment arm during the 9 day period from surgery through post-operative day 8. Feasibility will be monitored sequentially (after each patient completes study treatment), by arm. The feasibility review boundary is based on a Wald sequential probability ratio test. Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated.
- Incidence of toxicity [ Time Frame: Up to 30 days ]All grade toxicities attributed to dexamethasone at the possible or above level. All toxicities and side effects will be summarized in tables by organ, severity, and attribution. Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated.
- Volume of cerebral edema for each post-surgery brain magnetic resonance imaging (MRI) [ Time Frame: Up to 30 days ]Measured by strategically acquired gradient echo (STAGE).
- Qualitative assessments of cerebral edema on serial fluid-attenuated inversion recovery (FLAIR) images for each post-surgery brain MRI [ Time Frame: Up to 30 days ]Descriptive statistics will be provided for cerebral edema volume as measure by STAGE for each arm by strata and time point.
- Volume of cerebral edema for pre-operative and post-operative day 1 brain MRIs as measured by STAGE [ Time Frame: At pre-operative and post-operative day 1 ]Descriptive statistics will be provided for cerebral edema volume as measure by STAGE for each arm by strata and time point.
- Qualitative assessments of cerebral edema on serial FLAIR images for pre-operative and post-operative day 1 brain MRIs [ Time Frame: At pre-operative and post-operative day 1 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant is 18 years or older.
- Participant has a Karnofsky Performance Status of >= 60%.
- Participant has a primary or metastatic brain tumor(s).
- Participant can have newly diagnosed or recurrent brain tumor(s).
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If a participant is requiring more than 3 mg orally every 12 hours (q 12 h) of dexamethasone at the time of signing the consent form, it is anticipated by the neurosurgeon that the participant will be able to taper down their dose of dexamethasone to 3 mg orally q 12 h by 3 days before the surgery.
- (Note: If the patient is not able to decrease their dose of dexamethasone to 3 mg orally q 12 h 3 days before surgery, the patient will not be allowed to participate in the study.)
- Participant must have less than 10 mm of midline shift seen on pre-op brain magnetic resonance imaging (MRI).
- The neurosurgeon anticipates being able to perform a gross total resection of tumor.
- Participant is not planning to participate in another clinical trial during the study period.
- There is no limit to the number of prior therapies for enrollment in this study.
- All participants must have the ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
- Participant is unable to undergo a brain MRI.
- Participant is unable to tolerate dexamethasone.
- Participant has a chronic or active viral infection of the central nervous system (CNS).
- Participant has a coagulopathy or bleeding disorder.
- Participant has an uncontrolled illness including ongoing or active infection.
- Participant has another active malignancy.
- A patient has a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05139043
| United States, California | |
| City of Hope Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Jana L. Portnow 626-218-9200 jportnow@coh.org | |
| Principal Investigator: Jana L. Portnow | |
| Principal Investigator: | Jana L Portnow | City of Hope Medical Center |
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT05139043 |
| Other Study ID Numbers: |
20624 NCI-2021-11292 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 20624 ( Other Identifier: City of Hope Medical Center ) P30CA033572 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 1, 2021 Key Record Dates |
| Last Update Posted: | August 5, 2022 |
| Last Verified: | August 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Dexamethasone Dexamethasone acetate Ichthammol BB 1101 Anti-Inflammatory Agents Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dermatologic Agents |