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

Trial Summary

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.

What data supports the effectiveness of the drug BiCNU (carmustine) for treating lymphoma?

Carmustine (BCNU) is part of standard treatment regimens like BEAM and BEAC for lymphoma, which have shown effectiveness and low nonrelapse mortality. These regimens are considered effective components of high-dose chemotherapy followed by stem cell transplantation, a treatment option for chemosensitive lymphoma. ^{1 2 3 4 5}

Is carmustine generally safe for humans?

Carmustine, also known as BiCNU, has been associated with some side effects, especially at high doses. It can cause heart problems like myocardial ischemia (reduced blood flow to the heart) and symptoms such as severe headaches, tingling around the mouth, and facial flushing. These side effects should be considered when using high-dose carmustine. ^{4 6 7 8 9}

How is the drug BiCNU (carmustine) unique for treating lymphoma?

BiCNU (carmustine) is unique for treating lymphoma as it is part of the BEAM regimen, a widely used conditioning treatment for autologous stem cell transplants in Hodgkin lymphoma. It is often replaced by other drugs like bendamustine in alternative regimens, highlighting its specific role in traditional protocols. ^{4 6 10 11 12}

What is the purpose of this trial?

A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.

Eligibility Criteria

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

Active hepatitis B or C viral infection or HBsAg positive

My bone marrow harvest was not enough for a transplant.

I have had a stem cell transplant before.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Investigation of gemcitabine plus lomustine treatment in mice with transplantable lymphosarcoma LIO-1]. [2022]

2. United States 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. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of Implementing a Bendamustine-Based Conditioning Regimen on Outcomes of Autologous Stem Cell Transplantation in Lymphoma while Novel Cellular Therapies Emerge. [2023]

4. England pubmed.ncbi.nlm.nih.gov

BendaEAM versus BEAM as conditioning regimen for ASCT in patients with relapsed lymphoma (BEB): a multicentre, randomised, phase 2 trial. [2023]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Combined effect of gemcitabine and lomustine in mice with intracranial transplanted lymphosarcoma LIO-1]. [2022]

6. Turkey pubmed.ncbi.nlm.nih.gov

Autologous noncryopreserved hematopoietic stem cell transplant with CEAM as a modified conditioning regimen in patients with Hodgkin lymphoma: a single-center experience with a new protocol. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Pilot clinical study of carmustine associated with a lipid nanoemulsion in combination with vincristine and prednisone for the treatment of canine lymphoma. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Myocardial ischemia associated with high-dose carmustine infusion. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Headache, circumoral paresthesia, and facial flushing associated with high-dose carmustine infusion. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Lomustine (CCNU) for the treatment of resistant lymphoma in dogs. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Topical carmustine (BCNU) for cutaneous T cell lymphoma: a 15-year experience in 143 patients. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Combination chemotherapy with continuous L-asparaginase, lomustine, and prednisone for relapsed canine lymphoma. [2016]