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Phase II Trial of Interleukin-12 (NSC #672423, IND #6798) Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma

Phase 2
18 Years
Not Enrolling
Recurrent Melanoma, Stage IV Melanoma

Thank you

Trial Information

Phase II Trial of Interleukin-12 (NSC #672423, IND #6798) Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma


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.


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.

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

- 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

- 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

- 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)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

William Carson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

October 2001

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma



Cancer and Leukemia Group B Chicago, Illinois  60606