Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061048
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
2003-05-20
Brief Title:
Campath-1H for Treating Adult T-Cell LeukemiaLymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Study of the Efficacy and Toxicity of Campath-1H in the Therapy of Adult T-Cell Leukemia
Status:
COMPLETED
Status Verified Date:
2012-10
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 study will examine the safety and effectiveness of Alemtuzumab Campath-1H for treating patients with adult T-cell leukemialymphoma ATL ATL is caused by a virus called human T-cell lymphotrophic virus type-1 HTLV-1 that infects lymphocytes white blood cells called T-cells Cancerous cells can be found not only in the blood but also in the skin lungs lymph nodes liver bone bone marrow spleen and meninges tissues covering the brain There are four categories of ATL based on the aggressiveness of disease-smoldering chronic lymphoma and acute Campath-1H is a monoclonal antibody that attaches to and kills normal and cancerous lymphocytes including T cells Although Campath-1H is an experimental drug for treating ATL it is approved by the Food and Drug Administration for treating chronic lymphocytic leukemia
Patients 18 years of age and older with any type of ATL except smoldering may be eligible for this study Candidates are screened with a medical history and physical examination photos of skin lesions measurement of lesions such as lymph nodes and skin nodules blood and urine tests electrocardiogram EKG chest x-ray computed tomography CT scan or ultrasound of the abdomen skin biopsy bone marrow aspirate and biopsy skin test and lumbar puncture spinal tap Participants undergo treatment in two phases as follows
Dose escalation phase Patients receive an infusion of Campath-1H daily for three days The initial dose is low and is increased daily as long as there are no side effects or only mild reactions until the patient is receiving the maximum dose of 30 milligrams per day
Stable dose phase Patients receive infusions of Campath-1H 30 mg three times a week for up to 12 weeks
In addition to treatment patients are evaluated with the following tests and procedures
History and physical examination every 4 weeks
Blood tests every 4 weeks
CT scans to measure the size of the tumors every 4 weeks
Skin biopsies if skin disease is present and lymph note aspirates Up to five biopsies and five aspirates may be taken to help diagnose the disease and evaluate the effect of Campath-1H on the cancer
Bone marrow biopsy This procedure may be done to document or monitor disease progress
Patients receive treatment for up to 12 weeks Treatment may stop earlier if the patient achieves a complete response before the end of 12 weeks Patients completing the study are followed periodically with a history and physical examination blood and urine tests tumor evaluation skin biopsy and skin testing They are seen monthly at first and then at 3-month intervals the first year every 4 months the second year every 6 months for the third through fifth years and then yearly
Patients 18 years of age and older with any type of ATL except smoldering may be eligible for this study Candidates are screened with a medical history and physical examination photos of skin lesions measurement of lesions such as lymph nodes and skin nodules blood and urine tests electrocardiogram EKG chest x-ray computed tomography CT scan or ultrasound of the abdomen skin biopsy bone marrow aspirate and biopsy skin test and lumbar puncture spinal tap Participants undergo treatment in two phases as follows
Dose escalation phase Patients receive an infusion of Campath-1H daily for three days The initial dose is low and is increased daily as long as there are no side effects or only mild reactions until the patient is receiving the maximum dose of 30 milligrams per day
Stable dose phase Patients receive infusions of Campath-1H 30 mg three times a week for up to 12 weeks
In addition to treatment patients are evaluated with the following tests and procedures
History and physical examination every 4 weeks
Blood tests every 4 weeks
CT scans to measure the size of the tumors every 4 weeks
Skin biopsies if skin disease is present and lymph note aspirates Up to five biopsies and five aspirates may be taken to help diagnose the disease and evaluate the effect of Campath-1H on the cancer
Bone marrow biopsy This procedure may be done to document or monitor disease progress
Patients receive treatment for up to 12 weeks Treatment may stop earlier if the patient achieves a complete response before the end of 12 weeks Patients completing the study are followed periodically with a history and physical examination blood and urine tests tumor evaluation skin biopsy and skin testing They are seen monthly at first and then at 3-month intervals the first year every 4 months the second year every 6 months for the third through fifth years and then yearly
Detailed Description:
Background
Adult T-cell leukemialymphoma ATL is an aggressive lymphoproliferative disorder caused by an infection with the human T-cell lymphotrophic virus type-1 HTLV-1
ATL is characterized by rapidly rising peripheral blood leukemia cell counts lymphadenopathy lytic bone lesions hepatosplenomegaly and skin and solid organ involvement by tumor
Chemotherapy has shown modest activity and the treatment of ATL has remained largely undefined and the survival of ATL patients poor
The CD52 surface glycoantigen is overexpressed on ATL cells
Alemtuzumab Campath-1H is a humanized rat monoclonal antibody that binds to CD52 and is cytotoxic
In preclinical models Campath-1H inhibited tumor growth and improved the survival of Non-obese diabetic NODsevere combined immune deficiency SCID mice injected with human MET-1 ATL cells
Objectives
To determine the efficacy of Campath-1H in the treatment of ATL
To define the time course of Campath-1H saturation in patients with ATL
To define the toxicity of Campath-1H in patients with ATL
Eligibility
Patients with HTLV-I-associated adult T-cell leukemia
More than 10 of the malignant cells must express CD52 and CD25
Patients must have measurable disease
The patient must have a granulocyte count of at least 1000mm3 and a platelet count of greater than or equal to 50000mm3
Design
A single institution non-randomized open-label Phase II trial
This trial will recruit a maximum of 30 eligible patients
Patients will receive antimicrobial and antiviral prophylaxis while on-study due to the known immunosuppressive effects of Campath-1H
Patients will receive IV Campath-1H 3 mg on day 1 10 mg on day 2 and 30 mg day 3 followed by maintenance Campath-1H 30 mg IV three time per week
Patients will be evaluated for response and continuation of Campath-1H therapy after weeks 4 and 8 of maintenance treatment
Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment
Adult T-cell leukemialymphoma ATL is an aggressive lymphoproliferative disorder caused by an infection with the human T-cell lymphotrophic virus type-1 HTLV-1
ATL is characterized by rapidly rising peripheral blood leukemia cell counts lymphadenopathy lytic bone lesions hepatosplenomegaly and skin and solid organ involvement by tumor
Chemotherapy has shown modest activity and the treatment of ATL has remained largely undefined and the survival of ATL patients poor
The CD52 surface glycoantigen is overexpressed on ATL cells
Alemtuzumab Campath-1H is a humanized rat monoclonal antibody that binds to CD52 and is cytotoxic
In preclinical models Campath-1H inhibited tumor growth and improved the survival of Non-obese diabetic NODsevere combined immune deficiency SCID mice injected with human MET-1 ATL cells
Objectives
To determine the efficacy of Campath-1H in the treatment of ATL
To define the time course of Campath-1H saturation in patients with ATL
To define the toxicity of Campath-1H in patients with ATL
Eligibility
Patients with HTLV-I-associated adult T-cell leukemia
More than 10 of the malignant cells must express CD52 and CD25
Patients must have measurable disease
The patient must have a granulocyte count of at least 1000mm3 and a platelet count of greater than or equal to 50000mm3
Design
A single institution non-randomized open-label Phase II trial
This trial will recruit a maximum of 30 eligible patients
Patients will receive antimicrobial and antiviral prophylaxis while on-study due to the known immunosuppressive effects of Campath-1H
Patients will receive IV Campath-1H 3 mg on day 1 10 mg on day 2 and 30 mg day 3 followed by maintenance Campath-1H 30 mg IV three time per week
Patients will be evaluated for response and continuation of Campath-1H therapy after weeks 4 and 8 of maintenance treatment
Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H 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 |
|---|---|---|---|
| 030194 | OTHER | Clinical Center CC National Institutes of Health NIH | None |
| 03-C-0194 | OTHER | None | None |