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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00026143 |
Purpose
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining interleukin-12 and interferon alfa may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in treating patients who have metastatic malignant melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Cutaneous Melanoma |
Biological: recombinant interferon alfa Biological: recombinant interleukin-12 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Interleukin-12 (NSC #672423, IND #6798) Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma |
| Enrollment: | 38 |
| Study Start Date: | September 2001 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IL-12 followed by IFN-alpha Therapy
Treatment of metastatic malignant melanoma patients with interleukin-12 followed by interferon-alpha.
|
Biological: recombinant interferon alfa
3 MU sub Q injection on Days 2-6 of each 14 day cycle
Biological: recombinant interleukin-12
300 ng/kg IV bolus on Day 1 of each 14 day cycle
|
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients are reassessed after 6 courses. Patients with a complete response receive 2 additional courses. Patients with a partial response or stable disease continue treatment in the absence of disease progression.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 6-12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cutaneous melanoma
At least 1 unidimensionally measurable lesion
The following are not considered measurable:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 79 Study Locations| Study Chair: | William E. Carson, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
| Responsible Party: | Monica M Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00026143 History of Changes |
| Other Study ID Numbers: | CDR0000068990, U10CA031946, CALGB-500001 |
| Study First Received: | November 9, 2001 |
| Last Updated: | April 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV melanoma recurrent melanoma |
|
Melanoma Skin Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Neoplasms by Site Skin Diseases Interferon-alpha Interferon Alfa-2a Interferons |
Interleukin-12 Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Adjuvants, Immunologic |