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D2C7-IT + Atezolizumab for Glioma
Study Summary
This trial is testing a new cancer drug in people with a certain type of brain tumor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My tumor has or might have a specific genetic feature, and I've had chemotherapy before.My brain tumor is a grade IV glioma that has come back.I am 18 years old or older.I have worsening muscle weakness and muscle loss in my arms and legs.I have severe lung disease or my diabetes is not under control.I have a severe allergy to gadolinium.My platelet count is at least 100,000/µl without help, and over 125,000/µl for biopsy procedures.I am not pregnant or breastfeeding.My kidney function, measured by creatinine, is within the normal range.I am not currently being treated for any cancer other than my main diagnosis, except for treated skin cancer or cervical carcinoma in situ.I am able to care for myself but may not be able to do active work.I haven't finished all standard treatments, including surgery and radiation.I haven't had immunotherapy in the last 4 weeks or have recovered from its side effects.My brain tumor has returned and is a grade IV.I am 18 years old or older.My brain tumor is a grade IV glioma that has come back.My blood clotting tests are normal and I can pause my blood thinner if needed for surgery.My recurrent tumor was confirmed by a biopsy before starting D2C7-IT treatment.I haven't had chemotherapy or certain cancer drugs in the last 4 weeks and have recovered from any side effects.My recurrent tumor was confirmed by a biopsy before getting D2C7-IT treatment.I cannot become pregnant or get someone pregnant.My tumor's MGMT promoter is unmethylated, so I haven't had to undergo chemotherapy before joining this trial.I do not have severe heart disease.I have taken more than 4 mg of dexamethasone daily in the last 2 weeks.I cannot become pregnant or get someone pregnant.I haven't had radiation therapy in the last 12 weeks, or if I did, my cancer has still grown.My brain tumor has come back and is a grade IV.I have an autoimmune disease but haven't needed systemic treatment for it in the last 3 months.I do not have an active infection needing IV treatment or a fever over 99.5°F.My platelet count is high enough for the study and any needed procedures.My cancer has spread to my brain or spinal cord and is actively growing.I have an immunosuppressive disease or HIV.My blood clotting tests are normal and I can pause my blood thinner if needed for surgery.You are able to have a brain scan using MRI, including using a special dye if needed.I am able to care for myself but may not be able to do active work.
- Group 1: D2C7-IT (6920 ng/mL) + Atezolizumab
- Group 2: D2C7-IT (4613.2 ng/mL) + Atezolizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the Food and Drug Administration given their stamp of approval to D2C7-IT (4613.2 ng/mL via convection-enhanced delivery)?
"Our team at Power assigned a score of 1 to the safety data concerning D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) as this is only in its first phase, with limited evidence affirming its efficacy and safety thus far."
Has there ever been a similar study conducted prior to this one?
"To date, 350 ongoing studies utilizing D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) are being conducted across 1646 cities and 74 nations. The initial trial involving this drug began in 2008, sponsored by Hoffmann-La Roche with 720 enlisted participants who completed Phase 2 of the approval process. In the 13 years since then, 80 trials have been successfully concluded."
What is the maximum capacity for participants in this experiment?
"Affirmative. The study, which was announced on the 20th of March 2020 and recently updated on 22nd of March 2022, is actively seeking patients to enrol in the trial across a single site. Clinicialtrials.gov confirms that 18 participants are needed for this project."
Are there any unfilled slots in this clinical trial?
"The clinical trial is currently enrolling patients, as indicated on the information found on clinicaltrials.gov. This particular medical study was first advertised in March of 2020 and its details have been modified most recently in March of 2022."
What conditions is D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) routinely utilized to treat?
"The experimental drug D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) is effective for treating small cell lung cancer, malignant neoplasms, and non-small cell lung carcinoma."
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