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Compares treatment options for Metastatic Lung Small Cell Carcinoma
Official title Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability
ClinicalTrials.gov ID: NCT04804644
What this study is testing
What is Memantine Hydrochloride?
Memantine Hydrochloride is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic lung small cell carcinoma.
Also referred to as Ebixia, Namenda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.
- Phase 3: a large, late-stage study
- Time commitment: about 24 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original...
- Patients with de novo or recurrent small cell lung cancer are permitted.
- Brain metastases =\< 4 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic...
- The total tumor volume must be 30 cm\^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on...
- Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and...
You likely can't join if
- Planned infusion of cytotoxic chemotherapy on the same day as SRS or HA-WBRT treatment. Patients may have had prior chemotherapy. Concurrent...
- For patients receiving fractionated SRS on an every-other-day basis, planned infusion of cytotoxic chemotherapy is not permitted between SRS...
- Brainstem metastasis \> 10 cm\^3
- Prior allergic reaction to memantine.
- Patients with definitive leptomeningeal metastases.
- Known history of demyelinating disease such as multiple sclerosis.
See the full eligibility criteria
Who can join
- Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological...
- Patients with de novo or recurrent small cell lung cancer are permitted.
- Brain metastases =\< 4 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =\< 21 days prior to study entry.
- The total tumor volume must be 30 cm\^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast enhanced, T1-weighted MRI and the product of those diameters will...
- Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer.
- Brain metastases must be diagnosed on MRI, which will include the following elements:
- REQUIRED MRI ELEMENTS
- Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE)...
- Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged).
- A minimum of one axial T2 FLAIR (preferred) or T2 sequence is required. This can be acquired as a two dimensional (2D) or 3D image. If 2D, the images should be obtained in the axial plane.
- ADDITIONAL RECOMMENDATIONS
- Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence.
- Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1.
- Recommendation is that imaging be performed on a 3 Tesla (3T) MRI.
- Recommendation is that the study participants be scanned on the same MRI instrument at each time point.
- Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020.
- If additional sequences are obtained, total imaging time should not exceed 60 minutes.
- If additional metastases not known at the time of registration/randomization or seen in the MRI used for eligibility are subsequently found on the radiation therapy (RT) planning MRI such that the total intacranial...
- History/physical examination
- Age \>= 18
- Karnofsky performance status of \>= 70
- Creatinine clearance \>= 30 ml/min
- Following the diagnosis of brain metastases, patients can initiate and treat with systemic (chemotherapy and/or immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in...
- Patients with symptomatic brain metastases and/or brain metastases in eloquent locations (e.g., brainstem, pre-/post central gyrus, visual cortex) are eligible for enrollment on the trial; however, the specific...
- Concurrent immunotherapy with brain radiation (SRS or HA-WBRT) is permitted.
- Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to registration. Women of childbearing potential and men who are sexually active must use contraception while on study.
- Patients may have had prior intracranial surgical resection.
- Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.
- The patient must provide study-specific informed consent prior to study entry.
- Patients with impaired decision-making capacity are not permitted on study.
- ELIGIBILITY CRITERIA PRIOR TO STEP 2 REGISTRATION
- The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive test will be uploaded into RAVE for evaluation by Dr. Wefel. Once the...
- NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.
- PRIOR TO STEP 2 REGISTRATION: The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive tests will be uploaded into RAVE for...
What rules you out
- Planned infusion of cytotoxic chemotherapy on the same day as SRS or HA-WBRT treatment. Patients may have had prior chemotherapy. Concurrent immunotherapy is permitted.
- For patients receiving fractionated SRS on an every-other-day basis, planned infusion of cytotoxic chemotherapy is not permitted between SRS treatments.
- Brainstem metastasis \> 10 cm\^3
- Prior allergic reaction to memantine.
- Patients with definitive leptomeningeal metastases.
- Known history of demyelinating disease such as multiple sclerosis.
- Contraindication to MR imaging such as implanted metal devices that are MRI-incompatible, allergy to MRI contrast that cannot be adequately addressed with pre-contrast medications, or foreign bodies that preclude MRI...
- Current use of (other N-methyl-D-aspartate [NMDA] antagonists) amantadine, ketamine, or dextromethorphan.
- Radiographic evidence of hydrocephalus or other architectural change of the ventricular system resulting in significant anatomic distortion of the hippocampus, including placement of external ventricular drain or...
- Mild cases of hydrocephalus not resulting in significant anatomic distortion of the hippocampus are permitted.
- Prior radiotherapy to the brain, including SRS, WBRT, or prophylactic cranial irradiation (PCI).
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Anaheim, California, United States
- Bellflower, California, United States
- Los Angeles, California, United States
- Ontario, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Greenwich, Connecticut, United States
- Guilford, Connecticut, United States
- New Haven, Connecticut, United States
- Trumbull, Connecticut, United States
- Waterford, Connecticut, United States
- Lewes, Delaware, United States
- Newark, Delaware, United States
- Rehoboth Beach, Delaware, United States
- Wilmington, Delaware, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
+ 159 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Anaheim, California, United States; Bellflower, California, United States; Los Angeles, California, United States; Ontario, California, United States; Aurora, Colorado, United States and 173 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.