BJ-005 for Advanced Solid Tumor or Lymphoma
This study is evaluating whether a drug called BJ-005 can be safely given to people with cancer.
See full descriptionAbout the trial for Advanced Solid Tumor or Lymphoma
Treatment Groups
This trial involves 2 different treatments. BJ-005 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether BJ-005 will improve 2 primary outcomes in patients with Advanced Solid Tumor or Lymphoma. Measurement will happen over the course of 60 days after the last dose.
Patient Q & A Section
How serious can lymphoma be?
Lymphoma is extremely serious and often fatal. Patients who survive longer than 5 years after diagnosis typically do so because they have better prognosis or because they respond to therapy. Even patients with early stages of non-Hodgkin's lymphoma may have prolonged survival if they are treated successfully.
Has bj-005 proven to be more effective than a placebo?
Randomized, double-blinded, placebo controlled study of 15 dogs with lymphoma. Bj-005 was found to be significantly more effective than a placebo in achieving remission (MELAS remission criteria), prolonging survival and decreasing tumor size after 3 months of treatment.
What is lymphoma?
Lymphoma and lymphomatous diseases constitute a group of neoplastic diseases that are characterized by the presence of abnormal B or T cells that have lost their ability to control growth and reproduce. They are classified based on histology, immunophenotype, genomic profile, biologic behavior, clinical course, treatment response and prognostic factors. Some lymphomas are associated with specific human viruses such as Epstein-Barr virus (EBV), Human papillomavirus (HPV), Kaposi Sarcoma-associated herpesvirus (KSHV), and human T-lymphotropic virus (HTLV). These viruses appear to play an important role in lymphoproliferation.
Does lymphoma run in families?
Recent findings suggest that familial aggregation of pediatric NHL may not be explained entirely by genes predisposing individuals to NHL. Larger studies are warranted to validate our conclusions.
What are the latest developments in bj-005 for therapeutic use?
A new formulation of bj-005 has significantly improved its water solubility when compared to the original formulation. The increased water solubility permits higher doses to be administered without an accompanying increase in toxicity. Further development efforts are underway to determine whether or not this formulation could be used as a prodrug option for bj-005.
How many people get lymphoma a year in the United States?
Approximately four out of every 100,000 Americans will develop lymphoma each year, with most cases occurring in middle age. The incidence of lymphoma appears to be increasing over time. The number of new cases of NHL may be higher than four out of every 100,000 per year in the US.
What are common treatments for lymphoma?
Common treatments include chemotherapy, radiation therapy, surgery, bone marrow transplantation, and targeted therapies. Often clinicians use multiple methods to treat the same patient. For example, some patients receive chemotherapy followed by radiation; others receive radiation followed by chemotherapy; and still others receive multiple rounds of treatment cycles. It should be noted that over half of all patients with non-Hodgkin's lymphoma will relapse within 5 years after their initial diagnosis. If the cancer develops resistance to the initial treatment, another approach may need to be tried, such as more intense chemotherapy or new targeted therapies. In general, the survivors tend to have longer life expectancies than those who do not survive.
What is the latest research for lymphoma?
The current treatment options are effective against many types of lymphomas and lead to long term remission. For advanced stages of lymphoma the outcome is dismal due to relapse following therapy. New data regarding the use of biologic response modifiers (e.g. Rituximab) are promising and should be considered. However, the optimal timing of such therapies remains unclear. Immunomodulation and immunotherapy are also being investigated and results are encouraging.
What causes lymphoma?
Lymphomas have diverse origins, but almost all are caused by genetic changes in white blood cells that result in uncontrolled proliferation of B cells. Causes may include infection with human T-lymphotropic virus 1 (HTLV-1) during early childhood, exposure to Epstein-Barr virus (EBV) in the second decade of life, and exposure to ionizing radiation in adulthood. Humans exposed to ionizing radiation especially during pregnancy tend to develop B cell lymphomas more frequently.
What is bj-005?
Results from a recent paper showed that bj-005 has autophagy inducing activity by inhibiting ATG7 expression and autophagy-associated protein 5L1, but did not affect other proteins associated with autophagy. Therefore, bj-005 could be considered as a potential new therapy for T/B cell lymphomas that overexpress ATG7.
Have there been any new discoveries for treating lymphoma?
In the past few decades, advances in technology have resulted in a vast increase in our understanding of the biology of lymphoma. The discovery of Bcl-2 has led to improved knowledge of the mechanisms by which the protein exerts its antiapoptotic effects. Data from a recent study are promising for the development of novel therapeutic strategies against lymphoma.