Carmustine for Lymphoma

Recruiting at 3 trial locations

Overseen By VIVUS Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VIVUS LLC

Must not be taking: Investigational drugs, Chemotherapy

Disqualifiers: Myelodysplasia, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

49 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two versions of the chemotherapy drug Carmustine to determine which is more effective for individuals with Hodgkin or Non-Hodgkin lymphoma preparing for a stem cell transplant. It compares VI-0609, which uses propylene glycol, with BiCNU, which uses ethanol, as part of a high-intensity conditioning regimen. Suitable candidates have already responded well to earlier treatments and are preparing for a stem cell transplant. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using other investigational medications or undergoing concurrent biological, chemotherapy, or radiation therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatment VI-0609, which combines carmustine with propylene glycol, is under evaluation for safety and effectiveness in people with lymphoma. Earlier studies have examined immediate side effects and any serious side effects that might appear later, aiming to ensure these can be managed.

BiCNU, a combination of carmustine with ethanol, has been studied previously and is approved for other uses. While generally considered safe, monitoring for new or unexpected side effects remains important when used differently or with new patients.

This trial is in a mid-stage, indicating some safety information from earlier studies is already available. This phase primarily gathers more detailed information about how well people tolerate the treatments in a larger group. Participants should feel reassured that safety remains a key focus of these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for lymphoma, which includes treatments like R-CHOP or ABVD, the study treatment VI-0609 offers a unique formulation by combining carmustine with propylene glycol. This formulation might improve the drug's solubility and delivery, potentially enhancing its effectiveness and reducing side effects compared to traditional formulations like BiCNU, which uses ethanol. Researchers are excited about VI-0609 because it represents a novel approach to delivering carmustine, offering the possibility of better patient outcomes with fewer adverse reactions.

What evidence suggests that this trial's treatments could be effective for lymphoma?

This trial will compare two forms of carmustine for treating lymphoma. BiCNU, a form of carmustine mixed with ethanol, has been used for years to treat lymphoma. VI-0609, another treatment option in this trial, is a new version of carmustine mixed with propylene glycol. Early research suggests that VI-0609 might be as effective as BiCNU in treating lymphoma. Both forms of carmustine interfere with the DNA of cancer cells, potentially stopping cancer growth. While more research is needed, these treatments show promise for people with lymphoma. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults over 18 with lymphoma, eligible for stem cell transplant, and a life expectancy of at least 6 months can join. They must have completed prior chemotherapy, collected enough stem cells for transplant, and show partial or complete response to treatment. Excluded are those with HIV/HBV/HCV/syphilis infections, previous transplants, significant radiation exposure to critical organs, use of other investigational treatments or persistent marrow involvement.

Inclusion Criteria

Seronegative for HIV Ag/Ab combo, HCV, active HBV, and syphilis

I am mostly able to care for myself.

My doctor thinks I am a good candidate for a specific type of stem cell transplant.

Exclusion Criteria

My bone marrow harvest was not enough for a transplant.

Active hepatitis B or C viral infection or HBsAg positive

I have had a stem cell transplant before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy Conditioning

Participants receive BEAM chemotherapy conditioning regimen with either VI-0609 or BiCNU

6 weeks

Autologous Hematopoietic Cell Transplantation (AHCT)

Participants undergo autologous hematopoietic cell transplantation following chemotherapy conditioning

1 week

Follow-up

Participants are monitored for safety and effectiveness after transplantation

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BiCNU
• VI-0609

Trial Overview The trial is testing VI-0609 versus BiCNU as part of the BEAM conditioning regimen before autologous hematopoietic cell transplantation (AHCT) in patients with Hodgkin or Non-Hodgkin lymphoma. It's a phase 2 study conducted across multiple centers.

How Is the Trial Designed?

Group I: VI-0609 Experimental Treatment 1 Intervention

VI-0609 (Carmustine with Propylene Glycol)

Group II: BiCNU Active Control 1 Intervention

BiCNU (Carmustine with Ethanol)

Who Is Running the Clinical Trial?

VIVUS LLC

Lead Sponsor

Trials

44

Recruited

10,600+

Published Research Related to This Trial

In a study of 52 adults with newly diagnosed high-grade astrocytomas, the combination of carmustine and cisplatin administered as a 72-hour continuous infusion showed significant activity, with 42% of patients achieving a partial response and a median survival time of 13 months.

The treatment was associated with manageable toxicity, including grade III to IV leukopenia in 32% of patients, but no treatment-related deaths or intracranial hemorrhages were reported, indicating a relatively safe profile for this chemotherapy regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of continuous infusion carmustine and cisplatin followed by cranial irradiation in adults with newly diagnosed high-grade astrocytoma. Grossman, SA., Wharam, M., Sheidler, V., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06915246

NCT06915246 | A Study of Carmustine With and Without ... A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas. Official Title. A ...

2. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/C215834

Clinical Trials Using Carmustine with Propylene Glycol ... Review the clinical trials studying carmustine with propylene glycol formulation vi-0609 on this list and use the filters to refine the results by age and ...

3. withpower.com withpower.com/trial/carmustine-for-lymphoma-e04cc

Carmustine for Lymphoma This Phase 2 medical study run by VIVUS LLC is evaluating whether BiCNU and VI-0609 will have tolerable side effects & efficacy for patients with Hodgkin's ...

4. ctsearchsupport.org ctsearchsupport.org/clinical-trials/a-study-of-carmustine-with-and-without-ethanol-in-subjects-with-lymphoma

A drug, carmustine (VI-0609), in combination with ethanol ... To find out if carmustine, either with ethanol or propylene glycol, is safe and works well to treat lymphoma before autologous BMT.

5. trial.medpath.com trial.medpath.com/drug/report/61ce86f1ada4b622

VI-0609 | Advanced Drug Monograph - MedPath The trial's primary endpoints focus on evaluating infusion-related toxicities within 24 hours post-infusion and unacceptable toxicities through ...