Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001832
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
1999-11-03
Brief Title:
Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Patients With Metastatic Melanoma Using Cloned Lymphocytes Following the Administration of a Non-Myeloablative But Lymphocyte Depleting Regimen
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This experiment will test the safety and effectiveness of a treatment for melanoma in which certain lymphocytes a type of white blood cell are taken from the patient grown in the laboratory and returned after the patients immune system has been weakened with immune-suppressing drugs Some patients will also receive interleukin-2 IL-2 a drug that may enhance the activity of the re-infused lymphocytes
Patients with metastatic melanoma melanoma whose tumor has spread who have been treated unsuccessfully with gp100 vaccination may participate in this study They will undergo apheresis or a tumor biopsy or both to collect lymphocytes In apheresis whole blood is drawn through a needle in the arm A machine separates the blood components and removes the white cells The rest of the blood is returned to the donor through a needle in the other arm A biopsy is a surgical procedure to remove a small piece of tumor tissue
Several weeks before the lymphocytes are collected patients will receive injections of growth colony stimulating factor G-CSF every day for five days This drug stimulates white cell production permitting as many cells as possible to be obtained during collection The lymphocytes will then be grown in larger numbers in the laboratory
Seven days before the cells are re-infused the patient is admitted to the hospital and a catheter small tube is placed in a large vein in the chest or neck Two drugs cyclophosphamide and fludarabine are given through the tube These drugs suppress the immune system so that it will not interfere with the work of the reinfused lymphocytes The lymphocytes are then injected through the catheter over a 30-minute period After the infusion patients who receive IL-2 will be given the drug in a high dose over a 15-minute period every eight hours for up to five days Patients whose condition does not permit high-dose IL-2 such as those with a heart condition or lung problem may receive a low-dose regimen with the drug given as a shot under the skin of the thigh or abdomen for five days followed by a 2-day break continuing for a total of six weeks These patients receive a higher dose the first week and then half that dose the next five weeks
Blood and tissue samples will be taken before and during the study to evaluate the size of the tumor and assess treatment If 3-5 weeks after therapy is completed the patients tumor has stabilized or shrunk the entire treatment except for chemotherapy may be repeated two more times
Patients with metastatic melanoma melanoma whose tumor has spread who have been treated unsuccessfully with gp100 vaccination may participate in this study They will undergo apheresis or a tumor biopsy or both to collect lymphocytes In apheresis whole blood is drawn through a needle in the arm A machine separates the blood components and removes the white cells The rest of the blood is returned to the donor through a needle in the other arm A biopsy is a surgical procedure to remove a small piece of tumor tissue
Several weeks before the lymphocytes are collected patients will receive injections of growth colony stimulating factor G-CSF every day for five days This drug stimulates white cell production permitting as many cells as possible to be obtained during collection The lymphocytes will then be grown in larger numbers in the laboratory
Seven days before the cells are re-infused the patient is admitted to the hospital and a catheter small tube is placed in a large vein in the chest or neck Two drugs cyclophosphamide and fludarabine are given through the tube These drugs suppress the immune system so that it will not interfere with the work of the reinfused lymphocytes The lymphocytes are then injected through the catheter over a 30-minute period After the infusion patients who receive IL-2 will be given the drug in a high dose over a 15-minute period every eight hours for up to five days Patients whose condition does not permit high-dose IL-2 such as those with a heart condition or lung problem may receive a low-dose regimen with the drug given as a shot under the skin of the thigh or abdomen for five days followed by a 2-day break continuing for a total of six weeks These patients receive a higher dose the first week and then half that dose the next five weeks
Blood and tissue samples will be taken before and during the study to evaluate the size of the tumor and assess treatment If 3-5 weeks after therapy is completed the patients tumor has stabilized or shrunk the entire treatment except for chemotherapy may be repeated two more times
Detailed Description:
Patients with metastatic melanoma who are human immunodeficiency virus HIV and Hepatitis B negative and who have previously progressed after receiving standard therapy will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine and then will be treated by the adoptive transfer of lymphocytes reactive with shared antigens on their tumors This study will evaluate the toxicity immunologic effects and potential therapeutic role of this treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0158 | None | None | None |