Ignite Creation Date:
2024-05-05 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00701298
Status:
TERMINATED
Last Update Posted:
2014-02-24
First Post:
2008-06-18
Brief Title:
Decitabine With or Without Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Inhibition of DNA Methylation by 1-Hr Infusion of 5-aza-2-Deoxycitidine Decitabine x 10 Days M-F With Escalating Doses of Sub-Q Pegylated PEG Interferon-alpha 2B PEG-Intron A Phase I Study With Molecular Correlates
Status:
TERMINATED
Status Verified Date:
2011-10
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 phase I trial is studying the side effects of decitabine when given together with or without interferon alfa-2b and the best dose of interferon alfa-2b in treating patients with unresectable or metastatic solid tumors Drugs used in chemotherapy such as decitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Biological therapies such as interferon alfa-2b may stimulate the immune system in different ways and stop tumor cells from growing It is not yet known whether decitabine is more effective when given with or without interferon alfa-2b in treating solid tumors
Detailed Description:
PRIMARY OBJECTIVES
I To assess toxicities of decitabine plus escalating doses of pegylated interferon alfa-2b PEG-Intron in patients with metastatic solid tumor
II To identify the dose-limiting toxicity of decitabine in combination with escalating doses of pegylated interferon alfa-2b in these patients
III To identify the maximum tolerated dose of pegylated interferon alfa-2b in combination with decitabine in these patients
SECONDARY OBJECTIVES
I To evaluate pretreatment and post-treatment blood and tumor samples to identify changes in global genomic DNA methylation
II To evaluate pretreatment and post-treatment blood skin and tumor samples to identify changes in Mage-1 mRNA and protein expression DNMT-1 levels due to sequestration by 5-azacytidine p53 induction evidence of DNA damage response as well as changes in levels of 25-oligoadenylate synthesis MxA and HLA class I as indicators of interferon response
III To evaluate complete and partial response rates in patients receiving decitabine in combination with escalating doses of pegylated interferon alfa-2b
OUTLINE
This is a dose-escalation study of pegylated interferon alfa-2b Patients are assigned to 1 of 2 treatment groups
GROUP 1 control Patients receive decitabine IV over 1 hour on days 1-5 and 8-12 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who experience disease progression after the first course of treatment may crossover to receive treatment in group 2
GROUP 2 Patients receive decitabine as in group 1 and pegylated interferon alfa-2b subcutaneously on days 1 8 15 and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo blood sample normal skin and tissue biopsy collection at baseline and periodically during study Blood normal skin and tissue samples are analyzed for global genomic DNA methylation gene-promoter methylation gene and protein expression p53 induction by DNA damage and interferon levels by high-performance pressure liquid chromatography and PCR methylation assays and for pharmacodynamic studies
After completion of study treatment patients are followed at 28 days and then every 3 months
I To assess toxicities of decitabine plus escalating doses of pegylated interferon alfa-2b PEG-Intron in patients with metastatic solid tumor
II To identify the dose-limiting toxicity of decitabine in combination with escalating doses of pegylated interferon alfa-2b in these patients
III To identify the maximum tolerated dose of pegylated interferon alfa-2b in combination with decitabine in these patients
SECONDARY OBJECTIVES
I To evaluate pretreatment and post-treatment blood and tumor samples to identify changes in global genomic DNA methylation
II To evaluate pretreatment and post-treatment blood skin and tumor samples to identify changes in Mage-1 mRNA and protein expression DNMT-1 levels due to sequestration by 5-azacytidine p53 induction evidence of DNA damage response as well as changes in levels of 25-oligoadenylate synthesis MxA and HLA class I as indicators of interferon response
III To evaluate complete and partial response rates in patients receiving decitabine in combination with escalating doses of pegylated interferon alfa-2b
OUTLINE
This is a dose-escalation study of pegylated interferon alfa-2b Patients are assigned to 1 of 2 treatment groups
GROUP 1 control Patients receive decitabine IV over 1 hour on days 1-5 and 8-12 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who experience disease progression after the first course of treatment may crossover to receive treatment in group 2
GROUP 2 Patients receive decitabine as in group 1 and pegylated interferon alfa-2b subcutaneously on days 1 8 15 and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo blood sample normal skin and tissue biopsy collection at baseline and periodically during study Blood normal skin and tissue samples are analyzed for global genomic DNA methylation gene-promoter methylation gene and protein expression p53 induction by DNA damage and interferon levels by high-performance pressure liquid chromatography and PCR methylation assays and for pharmacodynamic studies
After completion of study treatment patients are followed at 28 days and then every 3 months
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 |
|---|---|---|---|
| R21CA122270 | NIH | CTEP | httpsreporternihgovquickSearchR21CA122270 |
| NCI-2009-00295 | REGISTRY | None | None |
| CDR0000597624 | None | None | None |
| NVCI-0725 | None | None | None |
| NVCI 07-25 | OTHER | None | None |
| 8224 | OTHER | None | None |