Hematologic Neoplasms Clinical Trial
Official title:
Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies
The purpose of this study is to determine the response rate of patients with T-cell malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin (Accutane).
Retinoids have shown activity in T-cell malignancies in past studies (both isotretinoin and
etretinate) with an overall response rate of about 60%. One third of those responses were
complete responses. Interferon-alpha has proven efficacy in wide ranges of human malignancies
including T-cell lymphomas as a single agent. A clinical trial was needed to evaluate the
response rate of these two agents combined.
Interferon is a normal body protein, which is made by cells after exposure to viruses. It
acts as a messenger to warn surrounding cells of invasions by viruses and, possibly, by
cancer cells. Isotretinoin is a synthetic form of Vitamin A which effects the growth of
normal cells and cancer cells.
Participants participating in this study will receive a combination of alpha-interferon and
isotretinoin. Alpha-interferon will be given once a day for an initial period of 12 weeks.
Participants will take the drug home, where a nurse or family member of the participant (who
can be trained at UTMDACC) will inject it just under the skin (SQ). Isotretinoin will be
given by mouth twice a day.
If a participant's disease does not show a response, the alpha-interferon and the
isotretinoin will be increased. If side effects occur, the dose of alpha-interferon and/or
isotretinoin will be decreased by 50%. If the side effects are severe, therapy will be
discontinued. If the participant's disease is unresponsive or worsens, the participant will
be taken off study and other treatments will be recommended.
Responding participants will be placed on a maintenance schedule for as long as they respond.
Up to 60 participants will be studied at UT M.D. Anderson Cancer Center to test the
effectiveness of this drug combination.
This is an investigational study. Alpha-interferon and isotretinoin are FDA approved and
commercially available.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03483194 -
Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care (REVEH)
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03735992 -
Mind-body Medicine for Patients With Malignant Hematological Diseases
|
N/A | |
| Recruiting |
NCT04959175 -
Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT04275154 -
Immunological Parameters, Neurocognitive Changes, Activity, & Driving Fitness in Patients Undergoing CAR-T Cell Therapy
|
||
| Terminated |
NCT00957580 -
Trial of Pimasertib in Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT00997386 -
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States
|
Phase 2 | |
| Completed |
NCT00389428 -
Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
|
Phase 1 | |
| Completed |
NCT02193880 -
Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
|
N/A | |
| Recruiting |
NCT00071045 -
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
|
||
| Not yet recruiting |
NCT05054231 -
Immunological Profile for Patients Treated With CAR-T Cells
|
N/A | |
| Completed |
NCT02650791 -
Platelet Transfusion Requirements in Hematopoietic Transplantation Pilot Study
|
Phase 3 | |
| Completed |
NCT01362179 -
National Marrow Donor Program Long-Term Donor Follow-Up
|
||
| Terminated |
NCT02900248 -
CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
|
||
| Terminated |
NCT03648372 -
A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03320915 -
Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT
|
Phase 2 | |
| Recruiting |
NCT06422533 -
Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients
|
N/A | |
| Terminated |
NCT02895529 -
A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy
|
Phase 4 | |
| Active, not recruiting |
NCT03680092 -
Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation
|
Phase 2 | |
| Recruiting |
NCT03083327 -
Prophylactic Early PN in HPT/BMT
|
N/A | |
| Recruiting |
NCT03743480 -
Early Palliative Care and Hematological Cancer Patients
|
N/A |