Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026143
First received: November 9, 2001
Last updated: June 4, 2013
Last verified: June 2013

November 9, 2001
June 4, 2013
October 2001
July 2004   (final data collection date for primary outcome measure)
  • Response rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • PFS [ Time Frame: From registration until time of documented progression of disease or death from any cause, assessed up to 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00026143 on ClinicalTrials.gov Archive Site
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Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
Phase II Trial of Interleukin-12 (NSC #672423, IND #6798) Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma

Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in treating patients who have metastatic malignant melanoma. 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.

PRIMARY OBJECTIVES:

I. To estimate the clinical response rates in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b.

II. To estimate the progression-free survival in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b.

SECONDARY OBJECTIVES:

I. To measure serum levels of interferon-gamma. II. To measure levels of JAK-STAT signaling intermediates in patient PBMCs and tumor samples.

III. To analyze interferon-alpha-induced STAT signaling in patient PBMCs. IV. To determine the expression of IFN-regulated genes in patient PBMCs and tumor tissues.

V. To determine the pattern of gene expression induced by treatment with IL-12 and interferon-alpha using DNA microarray techniques in patient PBMCs.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Melanoma
  • Stage IV Melanoma
  • Biological: recombinant interleukin-12
    Given IV
    Other Names:
    • cytotoxic lymphocyte maturation factor
    • IL-12
    • interleukin-12
    • natural killer cell stimulatory factor
    • Ro 24-7472
  • Biological: recombinant interferon alfa
    Given SC
    Other Names:
    • Alferon N
    • alpha interferon
    • IFN-A
    • Intron A
    • Roferon-A
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Arm I
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.
Interventions:
  • Biological: recombinant interleukin-12
  • Biological: recombinant interferon alfa
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
July 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological or cytological diagnosis of cutaneous melanoma and clinical evidence of distant, metastatic, non-resectable regional lymphatic, or extensive in transit recurrent disease
  • Patients must have measurable disease; measurable disease is defined as the presence of at least one measurable lesion; if the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology; measurable lesions are defined as lesions that can be accurately measured in at least one dimension with the longest diameter >= 20 mm using conventional techniques or >= 10 mm with spiral CT scan

    • Lesions that are considered intrinsically non-measurable include the following:

      • Bone lesions;
      • Leptomeningeal disease;
      • Ascites;
      • Pleural/pericardial effusion;
      • Inflammatory breast disease;
      • Lymphangitis cutis/pulmonis;
      • Abdominal masses that are not confirmed and followed by imaging techniques;
      • Lytic lesions;
      • Lesions that are situated in a previously irradiated area
  • No history of peripheral neuropathy, brain metastases or other central nervous system disease
  • No history of/active autoimmune disease, hemolytic anemia or concurrent requirement for corticosteroids, including topical or inhaled
  • No hepatitis BSAg, known HIV disease or other major active illness; patients with risk factors for HIV should be tested; patients with these illnesses are more likely to experience significant side effects from the study treatment
  • No history of severe peptic ulcer disease or gastrointestinal bleeding unless there is objective evidence that the condition is inactive or resolved
  • No uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection
  • No chemotherapy, radiotherapy, or anti-hormonal therapy within three weeks prior to the initiation of therapy on this study
  • No prior therapy with IL-12
  • No prior therapy with IFN-alpha for metastatic disease (e.g., biochemotherapy); prior adjuvant therapy with IFN-a is acceptable as long as the patient remained disease-free for 12 months or longer following the last IFN-a treatment
  • No prior cytokine therapy for metastatic disease (e.g., high-dose IL-2)
  • No more than one prior chemotherapy regimen
  • CTC (ECOG) performance status 0-1
  • Non-pregnant, non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control; women of child-bearing age will undergo pregnancy testing
  • ANC >= 1500/μL
  • Platelets >= 100,000/μL
  • Hemoglobin > 9 g/dL (may be post transfusion or may receive EPO)
  • U-HCG or Serum HCG Negative (if patient of child-bearing potential)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00026143
NCI-2012-02816, CALGB-500001, CDR0000068990, U10CA031946
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: William Carson Cancer and Leukemia Group B
National Cancer Institute (NCI)
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP