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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Melanoma; Stage IV Melanoma

Intervention: recombinant interleukin-12 (Biological); recombinant interferon alfa (Biological); laboratory biomarker analysis (Other)

Phase: Phase 2

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
William Carson, Principal Investigator, Affiliation: Cancer and Leukemia Group B

Summary

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.

Clinical Details

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

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

Primary outcome:

Response rate

PFS

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Cancer and Leukemia Group B, Chicago, Illinois 60606, United States
Additional Information

Starting date: October 2001
Last updated: June 4, 2013

Page last updated: August 23, 2015

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