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Alkylating agents
Combination Therapy for Metastatic Solid Cancer
Phase 2
Waitlist Available
Led By David G Bostwick, M.D., M.B.A.
Research Sponsored by Rampart Health, L.L.C.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will help researchers understand if the study treatment is effective and what side effects there may be.
Who is the study for?
Adults with metastatic solid cancers who have exhausted standard therapies or cannot tolerate them, and have a life expectancy of at least 6 months. They must have measurable disease, agree to use contraception, and meet specific health criteria including organ function tests. Pregnant women, those with only bone metastasis as the site of disease, certain heart conditions, recent immunosuppressive treatments or live vaccines are excluded.Check my eligibility
What is being tested?
The trial is testing a combination of Cytoxan (chemotherapy), cryosurgery (freezing cancer cells), GM-CSF (boosts immune system), Keytruda and Yervoy (both are immunotherapies). It aims to assess treatment efficacy and occurrence of adverse events in patients with advanced cancer.See study design
What are the potential side effects?
Potential side effects include allergic reactions to drugs like Cytoxan or monoclonal antibodies such as Keytruda and Yervoy; damage from cryosurgery; blood disorders from GM-CSF; fatigue; increased risk of infections due to immune system changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Endpoint: Efficacy
Secondary outcome measures
Efficacy of Cryosurgical Freezing and Multiplex Immunochemotherapy
Other outcome measures
Best overall response of confirmed PR or CR by independent radiology review
Duration of AEs/SAEs
Endpoint Evaluation
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single arm. Subjects receiving treatment.Experimental Treatment5 Interventions
Efficacy of Cryosurgical Freezing and Multiplex Immunochemotherapy as determined by overall response rate of radiographic changes according to iRECIST criteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytoxan
2007
Completed Phase 3
~1460
Cryosurgical freezing (cryosurgery)
2019
Completed Phase 2
~20
Yervoy Injectable Product
2019
Completed Phase 2
~20
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Who is running the clinical trial?
Rampart Health, L.L.C.Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
David G Bostwick, M.D., M.B.A.Principal InvestigatorRampart Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be at least 18 years old to participate and sign the consent form.The medication used in this study may harm a developing baby. You must use effective birth control before starting the study, throughout the study, and for 120 days after the study ends.You are allergic to Cyclophosphamide.You are allergic to GM-CSF.You are currently taking part in another study with a new medication or device, or you have participated in such a study within the last 4 weeks.You have a mental health or substance abuse condition that could make it difficult to follow the study requirements, as determined by the doctor in charge of the study.You are able to perform daily activities without assistance, with some limitations due to your medical condition.You have been diagnosed with a solid cancer, and you need to provide your medical reports, including pathology specimens and imaging results, to Rampart Health for a review.You have tried all other standard treatments for your condition and they have not worked. You may also not be eligible for or have refused other available treatments due to concerns about side effects or poor outcomes.You are allergic to monoclonal antibodies like nivolumab or pembrolizumab, or any of their components.Your doctor thinks you are likely to live for at least 6 more months.You have soft tissue abnormalities seen on imaging tests that suggest cancer has spread to other parts of your body. For patients with prostate cancer who undergo PSMA PET, only abnormalities that show up on both PET and CT or MRI scans will be considered signs of cancer spread.Your imaging scans show that your lymph nodes have spread and any lymph node measuring 1.5 cm or more is considered to have cancer.You agree to sign a document saying you understand the trial and give permission to participate.Cancer has spread to your bones, as seen on imaging tests. If you had a bone scan or PET scan, either one can show the cancer spread. For prostate cancer patients who had a PSMA PET, only spots that look like cancer spread will count.You have cancer that has spread to a part of your body where it would be too dangerous to perform a procedure to treat it.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm. Subjects receiving treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate amount of participants recruited for this trial?
"Affirmative. According to clinicaltrials.gov, the trial which debuted on May 19th 2021 is still enrolling participants. A total of 32 volunteers need to be brought in from a single site before its completion date (June 15th 2022)."
Answered by AI
What health issues have been successfully managed through this therapy?
"Malignant melanoma of the skin is often managed with this particular treatment. Additionally, it has proven to be an efficacious modality for managing recurrent cervical cancer, leukemia, and refractory/relapsed mediastinal large B-cell lymphoma."
Answered by AI
Is enrollment currently available for this clinical experiment?
"Clinicaltrials.gov records indicate that the study, which was initially posted on May 19th 2021, is still actively recruiting patients for participation. The most recent update to this listing happened on June 15th 2022."
Answered by AI
Has this regimen been granted regulatory authorization from the FDA?
"Our team at Power assigned this treatment a rating of 2 on the safety scale because it is currently in Phase 2, which means there is evidence that supports its security but no data has been collected regarding efficiency."
Answered by AI
Are there any previous studies that have explored the efficacy of this treatment?
"As of now, 2059 trials are running to examine this particular treatment. Of these live tests, 310 have entered Phase 3. Most studies are conducted in Philadelphia; however, 82422 sites across the world offer clinical trials for this therapy."
Answered by AI
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