Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003346
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I-II Trial of High-Dose Acetaminophen With Carmustine in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy consisting of acetaminophen plus carmustine in treating patients who have stage III or stage IV melanoma
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy consisting of acetaminophen plus carmustine in treating patients who have stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD and the optimal biologic dose OBD of high-dose acetaminophen when given alone and the MTD of carmustine when given with acetaminophen at the OBD in patients with metastatic melanoma Phase I closed to accrual 372001
Determine the dose of acetaminophen that results in maximal depletion of intracellular glutathione in these patients
Assess the antitumor activity of high-dose acetaminophen in these patients
Assess the toxicity and antitumor activity of carmustine when administered with high-dose acetaminophen in these patients
OUTLINE This is a dose-escalation study
Phase I closed to accrual 372001 Patients receive a single oral dose of acetaminophen then acetylcysteine IV over 20 hours beginning 6-8 hours after the acetaminophen This treatment is repeated 3 weeks later On day 1 of the first treatment patients also receive carmustine IV over 1 hour before the acetylcysteine Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients each receive escalating doses of acetaminophen to determine the optimal biological dose OBD The OBD is defined as the lowest dose at or preceding the maximum tolerated dose MTD that results in maximal depletion of glutathione The MTD is defined as the dose at which no more than 1 to 6 patients experience dose-limiting toxicity DLT
Once the OBD is established for acetaminophen cohorts of 3-6 patients each receive escalating doses of carmustine The MTD is defined as for acetaminophen Dose escalation does not proceed until all patients are observed for 6 weeks after receiving carmustine
Once the OBD for acetaminophen and MTD for carmustine are determined 3 more patients are treated at 3 week intervals instead of 6 weeks If no DLT is observed this is the dose and schedule for the phase II portion of the study
Phase II A cohort of 14 patients receives oral acetaminophen and acetylcysteine IV every 3 weeks Another cohort of 14 patients receives oral acetaminophen and acetylcysteine IV then oral acetaminophen carmustine IV and acetylcysteine IV 3 weeks later Patients continue therapy in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30-80 patients will be accrued for this study within 40 months
Determine the maximum tolerated dose MTD and the optimal biologic dose OBD of high-dose acetaminophen when given alone and the MTD of carmustine when given with acetaminophen at the OBD in patients with metastatic melanoma Phase I closed to accrual 372001
Determine the dose of acetaminophen that results in maximal depletion of intracellular glutathione in these patients
Assess the antitumor activity of high-dose acetaminophen in these patients
Assess the toxicity and antitumor activity of carmustine when administered with high-dose acetaminophen in these patients
OUTLINE This is a dose-escalation study
Phase I closed to accrual 372001 Patients receive a single oral dose of acetaminophen then acetylcysteine IV over 20 hours beginning 6-8 hours after the acetaminophen This treatment is repeated 3 weeks later On day 1 of the first treatment patients also receive carmustine IV over 1 hour before the acetylcysteine Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients each receive escalating doses of acetaminophen to determine the optimal biological dose OBD The OBD is defined as the lowest dose at or preceding the maximum tolerated dose MTD that results in maximal depletion of glutathione The MTD is defined as the dose at which no more than 1 to 6 patients experience dose-limiting toxicity DLT
Once the OBD is established for acetaminophen cohorts of 3-6 patients each receive escalating doses of carmustine The MTD is defined as for acetaminophen Dose escalation does not proceed until all patients are observed for 6 weeks after receiving carmustine
Once the OBD for acetaminophen and MTD for carmustine are determined 3 more patients are treated at 3 week intervals instead of 6 weeks If no DLT is observed this is the dose and schedule for the phase II portion of the study
Phase II A cohort of 14 patients receives oral acetaminophen and acetylcysteine IV every 3 weeks Another cohort of 14 patients receives oral acetaminophen and acetylcysteine IV then oral acetaminophen carmustine IV and acetylcysteine IV 3 weeks later Patients continue therapy in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30-80 patients will be accrued for this study within 40 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 |
|---|---|---|---|
| NCI-H98-0014 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066323 | REGISTRY | None | None |