Ignite Creation Date:
2024-05-05 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00525031
Status:
COMPLETED
Last Update Posted:
2020-09-23
First Post:
2007-08-31
Brief Title:
Temozolomide Alone or With Pegylated Interferon-Alpha 2b PGI in Melanoma Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Randomized Phase II Neoadjuvant Study of Temozolomide Alone or With Pegylated Interferon-alpha 2b in Patients With Resectable American Joint Committee on Cancer AJCC Stage IIIBIIIC or Stage IV M1a Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2020-09
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:
The goal of this clinical research study is to learn if temozolomide alone or given with pegylated interferon alpha-2b can help to control metastatic melanoma Researchers also want to study the safety of these 2 treatments
Objectives
1 To determine the anti-tumor activity pathological response CRPR and toxicity of temozolomide TMZ alone or in combination with pegylated interferon alpha-2b PGI in patients with resectable stage IIIC or stage IV M1a metastatic melanoma prior to definitive surgical resection
2 To determine the relapse-free survival overall survival and the impact of tumor response to chemotherapy in these patients
3 To differentiate the in vivo treatment effects of TMZ alone vsTMZ plus PGI and correlate with clinical outcome by analysis the pre- and post-treatment tumors and peripheral blood mononuclear cells with respect to
1 Known cellular and molecular markers of apoptosis and cell proliferation 2 Promotor methylation status of the DNA repair enzyme O6-methylguanine-DNA methyltransferase MGMT 3 DNA sequence variability of tumor suppressor genes and DNA repair enzymes 4 Tumor genomic expression profiles analysis by complementary DNA cDNA microarray and protein array
Objectives
1 To determine the anti-tumor activity pathological response CRPR and toxicity of temozolomide TMZ alone or in combination with pegylated interferon alpha-2b PGI in patients with resectable stage IIIC or stage IV M1a metastatic melanoma prior to definitive surgical resection
2 To determine the relapse-free survival overall survival and the impact of tumor response to chemotherapy in these patients
3 To differentiate the in vivo treatment effects of TMZ alone vsTMZ plus PGI and correlate with clinical outcome by analysis the pre- and post-treatment tumors and peripheral blood mononuclear cells with respect to
1 Known cellular and molecular markers of apoptosis and cell proliferation 2 Promotor methylation status of the DNA repair enzyme O6-methylguanine-DNA methyltransferase MGMT 3 DNA sequence variability of tumor suppressor genes and DNA repair enzymes 4 Tumor genomic expression profiles analysis by complementary DNA cDNA microarray and protein array
Detailed Description:
Temozolomide is a drug that is designed to work by stopping cancer cells from making new DNA If they cannot make DNA they cant split into 2 new cancer cells
Pegylated Interferon alpha-2b is a protein made by the human immune system that helps to fight viral infections and regulate cell function
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to one of two treatment groups Arm A or Arm B You have an equal chance of being assigned to either group and getting the treatment assigned to that group You will not know which group you are assigned to
Arm A Participants in this group will take temozolomide once a day for 7 days in a row This will be followed by 7 days without any treatment This will be repeated 3 more timesfor a total of 8 weeks - 1 cycle before you have routine surgery
Arm B Participants in this group will take temozolomide on the same schedule as those in Arm A However participants in this group will also receive pegylated interferon alpha-2b as an injection under the skin once a week for a total of 8 weeks before they have routine surgery Tylenol will be given to participants in this group before their pegylated interferon alpha-2b injection After the first injection they will also need to stay in the clinic for 2 hours of observation
Your body weight will be used when calculating the dosage of Temozolomide
You will have blood about 1 tablespoon each time drawn at 2 times to check your response to treatment The first sample will be drawn before you start treatment The second sample will be drawn around Day 57 of treatment
On Days 15 29 43 and 57 of treatment you will be asked about any illness you have experienced and any medications you may be taking You will have a physical exam including measurement of vital signs You will have tumor measurements and a performance status evaluation You will also have about 1 tablespoon of blood drawn for routine tests at each visit Any side effects you may have experienced will also be recorded
All participants will receive 1 cycle 8 weeks of treatment followed by surgery to remove the tumor The size of the tumor will be closely monitored during study treatment If the tumor increases in size by 50 half or greater study treatment will be stopped and you will immediately have surgery If you have to stop treatment due to side effects from the drugs you may be able to start up again once the side effect has gone away or decreased in severity enough However the time you are off therapy will count towards the total 8 weeks that you can receive treatment If recovery from the side effect requires a total of 8 weeks or more from the start of treatment you will be removed from the study and receive surgery Tumor and blood samples will be collected during surgery to check how the disease is responding to treatment
Your routine surgery will be scheduled to take place up to 90 days following completion of your treatment and as soon as your blood counts have recovered to the normal level
After surgery if you are experiencing side effects from the study drugs but show stable disease or you are responding to treatment you will be able to receive 3 additional cycles of therapy 24 weeks You will have a physical exam including measurement of vital signs and routine blood tests about 1 tablespoon every 4 weeks You will then be followed every 3 months with routine blood tests about 1 tablespoon each time for the first 3 years and every 6 months up to 8 years After that follow-up will be at the discretion of your primary physician CT scans of your chest abdomen and pelvis will be performed after each cycle of therapy for the 3 additional cycles then every 6 months up to 5 years and then at the discretion of your primary physician
This is an investigational study Temozolomide alone and given with pegylated interferon alpha-2b is authorized for use in research only Neither of these drugs is currently approved by the FDA for this treatment About 124 patients will be enrolled on this study All will be enrolled at M D Anderson
Pegylated Interferon alpha-2b is a protein made by the human immune system that helps to fight viral infections and regulate cell function
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to one of two treatment groups Arm A or Arm B You have an equal chance of being assigned to either group and getting the treatment assigned to that group You will not know which group you are assigned to
Arm A Participants in this group will take temozolomide once a day for 7 days in a row This will be followed by 7 days without any treatment This will be repeated 3 more timesfor a total of 8 weeks - 1 cycle before you have routine surgery
Arm B Participants in this group will take temozolomide on the same schedule as those in Arm A However participants in this group will also receive pegylated interferon alpha-2b as an injection under the skin once a week for a total of 8 weeks before they have routine surgery Tylenol will be given to participants in this group before their pegylated interferon alpha-2b injection After the first injection they will also need to stay in the clinic for 2 hours of observation
Your body weight will be used when calculating the dosage of Temozolomide
You will have blood about 1 tablespoon each time drawn at 2 times to check your response to treatment The first sample will be drawn before you start treatment The second sample will be drawn around Day 57 of treatment
On Days 15 29 43 and 57 of treatment you will be asked about any illness you have experienced and any medications you may be taking You will have a physical exam including measurement of vital signs You will have tumor measurements and a performance status evaluation You will also have about 1 tablespoon of blood drawn for routine tests at each visit Any side effects you may have experienced will also be recorded
All participants will receive 1 cycle 8 weeks of treatment followed by surgery to remove the tumor The size of the tumor will be closely monitored during study treatment If the tumor increases in size by 50 half or greater study treatment will be stopped and you will immediately have surgery If you have to stop treatment due to side effects from the drugs you may be able to start up again once the side effect has gone away or decreased in severity enough However the time you are off therapy will count towards the total 8 weeks that you can receive treatment If recovery from the side effect requires a total of 8 weeks or more from the start of treatment you will be removed from the study and receive surgery Tumor and blood samples will be collected during surgery to check how the disease is responding to treatment
Your routine surgery will be scheduled to take place up to 90 days following completion of your treatment and as soon as your blood counts have recovered to the normal level
After surgery if you are experiencing side effects from the study drugs but show stable disease or you are responding to treatment you will be able to receive 3 additional cycles of therapy 24 weeks You will have a physical exam including measurement of vital signs and routine blood tests about 1 tablespoon every 4 weeks You will then be followed every 3 months with routine blood tests about 1 tablespoon each time for the first 3 years and every 6 months up to 8 years After that follow-up will be at the discretion of your primary physician CT scans of your chest abdomen and pelvis will be performed after each cycle of therapy for the 3 additional cycles then every 6 months up to 5 years and then at the discretion of your primary physician
This is an investigational study Temozolomide alone and given with pegylated interferon alpha-2b is authorized for use in research only Neither of these drugs is currently approved by the FDA for this treatment About 124 patients will be enrolled on this study All will be enrolled at M D Anderson
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 |
|---|---|---|---|
| NCI-2010-00855 | REGISTRY | NCI CTRP | None |