Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048880
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-11-08
Brief Title:
Phase I Study of HeFi-1 to Treat Cancers With CD30 Protein
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of HeFi-1 in Refractory CD30-Positive Malignancy
Status:
COMPLETED
Status Verified Date:
2010-03-05
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:
Background
Some cancers such as Hodgkins disease anaplastic large cell lymphoma and others have a protein on the surface of the cancer cell called CD30
HeFi-1 is an antibody that binds to the CD30 protein and sends signals to the cancer cells that can cause them to die
Objectives
To determine the highest dose of HeFi-1 that can safely be given to patients with tumors that have the CD30 protein
To determine the response of the tumor to treatment with HeFi-1
Eligibility
Patients 18 years of age and older with Hodgkins disease anaplastic large cell lymphoma cutaneous T cell lymphoma and adult T cell leukemia or lymphoma who have signs of tumor growth or recurrence following standard treatment
Patients tumor cells must have the CD30 protein
Design
Groups of three patients are treated with increasingly higher doses of HeFi-1 ranging from 05 to 5 mgkg to determine the highest safe dose
HeFi-1 is infused through a vein on 4 days followed by 2 days of rest over a 10-day period Patients may receive up to 2 treatment courses if they show some response and do not have severe side effects
Blood samples are collected several times during the study to determine safety A lymph node biopsy is done at the beginning of the study to test the effect of HeFi-1 on cancer cells in the test tube and a bone marrow biopsy may be done at the end of treatment if the bone marrow was positive for tumor cells at the beginning of treatment
Some cancers such as Hodgkins disease anaplastic large cell lymphoma and others have a protein on the surface of the cancer cell called CD30
HeFi-1 is an antibody that binds to the CD30 protein and sends signals to the cancer cells that can cause them to die
Objectives
To determine the highest dose of HeFi-1 that can safely be given to patients with tumors that have the CD30 protein
To determine the response of the tumor to treatment with HeFi-1
Eligibility
Patients 18 years of age and older with Hodgkins disease anaplastic large cell lymphoma cutaneous T cell lymphoma and adult T cell leukemia or lymphoma who have signs of tumor growth or recurrence following standard treatment
Patients tumor cells must have the CD30 protein
Design
Groups of three patients are treated with increasingly higher doses of HeFi-1 ranging from 05 to 5 mgkg to determine the highest safe dose
HeFi-1 is infused through a vein on 4 days followed by 2 days of rest over a 10-day period Patients may receive up to 2 treatment courses if they show some response and do not have severe side effects
Blood samples are collected several times during the study to determine safety A lymph node biopsy is done at the beginning of the study to test the effect of HeFi-1 on cancer cells in the test tube and a bone marrow biopsy may be done at the end of treatment if the bone marrow was positive for tumor cells at the beginning of treatment
Detailed Description:
BACKGROUND
The scientific basis for this study is the observation that antibodies directed at the ligand-binding site of CD30 induce apoptosis in vitro and cure animals bearing CD30-positive tumors
HeFi-1 a murine monoclonal antibody developed at the NCI specifically binds human CD30 a member of the tumor necrosis receptor superfamily at the ligand-binding site
CD30 is expressed on activated T-cells Reed-Sternberg cells anaplastic large cell lymphoma and some AIDS-related lymphoma cells
Tumor cells from patients with anaplastic large cell lymphoma are sensitive to the effects of HeFi-1 but Hodgkins disease cell lines show variable responsiveness due to the presence of mutations in I B kinase which result in constitutive activation of NF- B
OBJECTIVE
The primary objective of this study is to determine the toxicity and maximum tolerated dose of HeFi-1 in patients with CD30-positive malignancy
This study will explore the pharmacokinetics dose required to saturate CD30 binding sites in tumor aspirates and the frequency and time course of onset of development of human anti-mouse antibody HAMA
These studies will allow us to monitor in a preliminary fashion the clinical tumor response measured by reduction in tumor lesions and by following the tumor marker serum soluble interleukin 2 receptor
ELIGIBILITY
Patients with measurable or evaluable CD30-positive lymphoma who have become refractory to standard therapy including Hodgkins disease systemic anaplastic large cell lymphoma cutaneous T cell lymphoma and adult T cell leukemialymphoma are eligible for treatment
DESIGN
This is a phase I dose-escalation trial in which cohorts of three patients will be treated with HeFi-1 ranging from 05 to 5 mgkgdose total dose of 2 to 20 mgkg per treatment course
Four doses will be given on an every three days schedule over a 10-day period for each cycle
Two cycles of therapy will be administered provided the patient has had a partial or complete response and has not developed dose-limiting toxicity or HAMA
The scientific basis for this study is the observation that antibodies directed at the ligand-binding site of CD30 induce apoptosis in vitro and cure animals bearing CD30-positive tumors
HeFi-1 a murine monoclonal antibody developed at the NCI specifically binds human CD30 a member of the tumor necrosis receptor superfamily at the ligand-binding site
CD30 is expressed on activated T-cells Reed-Sternberg cells anaplastic large cell lymphoma and some AIDS-related lymphoma cells
Tumor cells from patients with anaplastic large cell lymphoma are sensitive to the effects of HeFi-1 but Hodgkins disease cell lines show variable responsiveness due to the presence of mutations in I B kinase which result in constitutive activation of NF- B
OBJECTIVE
The primary objective of this study is to determine the toxicity and maximum tolerated dose of HeFi-1 in patients with CD30-positive malignancy
This study will explore the pharmacokinetics dose required to saturate CD30 binding sites in tumor aspirates and the frequency and time course of onset of development of human anti-mouse antibody HAMA
These studies will allow us to monitor in a preliminary fashion the clinical tumor response measured by reduction in tumor lesions and by following the tumor marker serum soluble interleukin 2 receptor
ELIGIBILITY
Patients with measurable or evaluable CD30-positive lymphoma who have become refractory to standard therapy including Hodgkins disease systemic anaplastic large cell lymphoma cutaneous T cell lymphoma and adult T cell leukemialymphoma are eligible for treatment
DESIGN
This is a phase I dose-escalation trial in which cohorts of three patients will be treated with HeFi-1 ranging from 05 to 5 mgkgdose total dose of 2 to 20 mgkg per treatment course
Four doses will be given on an every three days schedule over a 10-day period for each cycle
Two cycles of therapy will be administered provided the patient has had a partial or complete response and has not developed dose-limiting toxicity or HAMA
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 |
|---|---|---|---|
| 03-C-0038 | None | None | None |