Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004244
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
2000-01-28
Brief Title:
Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of rhIL-12 and rHuIFN-a2b in Patients With Metastatic Renal Cell Carcinoma or Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2005-06
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:
This phase I trial is studying the side effects and best dose of interleukin-12 and interferon alfa in treating patients with metastatic kidney cancer or malignant melanoma Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons white blood cells to kill cancer cells Interferon alfa may interfere with the growth of cancer cells Combining interleukin-12 and interferon alfa may kill more cancer cells
Detailed Description:
OBJECTIVES
I Determine the toxicity of interleukin-12 and interferon alfa in patients with metastatic renal cell carcinoma or malignant melanoma
II Determine the maximum tolerated dose of these drugs when concurrently administered in this patient population
III Obtain preliminary data on the antitumor efficacy of this combination in these patients
OUTLINE This is a dose-escalation study followed by a randomized study
Patients receive interleukin-12 subcutaneously SC twice a week and interferon alfa SC three times a week every week for 4 weeks Treatment continues in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities
Once the MTD is established additional patients are accrued and randomized to 1 of the following treatment arms
ARM I Patients receive interleukin-12 SC twice a week for 2 weeks followed by treatment with interleukin-12 in combination with interferon alfa as described above
ARM II Patients receive interferon alfa SC three times a week for 2 weeks followed by treatment with interleukin-12 in combination with interferon alfa as described above
ARM III Patients receive treatment with interleukin-12 in combination with interferon alfa at the MTD as described above
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for the dose escalation portion of this study An additional 18 patients 5 in arm I 5 in arm II and 8 in arm III will be accrued to the randomized portion of this study
I Determine the toxicity of interleukin-12 and interferon alfa in patients with metastatic renal cell carcinoma or malignant melanoma
II Determine the maximum tolerated dose of these drugs when concurrently administered in this patient population
III Obtain preliminary data on the antitumor efficacy of this combination in these patients
OUTLINE This is a dose-escalation study followed by a randomized study
Patients receive interleukin-12 subcutaneously SC twice a week and interferon alfa SC three times a week every week for 4 weeks Treatment continues in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities
Once the MTD is established additional patients are accrued and randomized to 1 of the following treatment arms
ARM I Patients receive interleukin-12 SC twice a week for 2 weeks followed by treatment with interleukin-12 in combination with interferon alfa as described above
ARM II Patients receive interferon alfa SC three times a week for 2 weeks followed by treatment with interleukin-12 in combination with interferon alfa as described above
ARM III Patients receive treatment with interleukin-12 in combination with interferon alfa at the MTD as described above
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for the dose escalation portion of this study An additional 18 patients 5 in arm I 5 in arm II and 8 in arm III will be accrued to the randomized portion of this study
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-T99-0028 | None | None | None |
| CCF-IRB-3063 | None | None | None |