Combination Therapy of Interleukin-12 and Interleukin-2 to Treat Advanced Cancer

Stopped early · Phase 1

Conditions studied: Kidney Neoplasm, Lung Neoplasm, Sarcoma, Breast Neoplasm

In brief

The purposes of this study are fourfold. It will 1) determine what dose of interleukin-12 (IL-12) and interleukin-2 (IL-2) combination therapy can be given safely to patients with advanced cancer; 2) evaluate the side effects of this treatment; 3) examine how the body handles this drug combination; and 4) determine whether and how the therapy may cause the immune system to stop or slow tumor growth. IL-2 is an approved drug for treating melanoma and kidney cancer. IL-12 is an experimental drug that has shown anti-cancer activity in animals, shrinking tumors and slowing their growth. Animal studies suggest that given together, the drugs may be more effective against cancer than either one singly. Patients 18 years of age and older with advanced solid-tumor cancers (kidney, breast, lung, sarcomas and others) that do not improve with standard treatment may qualify for this study. Candidates will have a physical examination, including blood and urine tests, electrocardiogram (EKG) and echocardiogram, DTH skin test (to test the function of the immune system), chest X-ray and lung function tests to determine eligibility. Bone marrow biopsy and imaging procedures such as CT and MRI scans may also be required. Patients over 50 years old will also undergo exercise stress testing. Treatment will consist of four courses of IL-2 and IL-12. On days one and nine of each course, patients will receive three doses (one every 8 hours) of IL-2 intravenously (through a vein). On days two, four, six, 10, 12 and 14, they will receive IL-12 intravenously. This will be followed by a recovery period from days 15 through 35. This regimen will be repeated for another three cycles; patients who show benefit without severe side effects may continue for additional cycles. Treatment for the first cycle will be administered in the hospital. If the drugs are well tolerated, additional therapy may be given on an outpatient basis. A biopsy (removal of a small sample of tumor tissue) will be done at the beginning of the study, after completing the first treatment cycle, and possibly again when the cancer slows, stops or gets worse, or if the patient leaves the study. These tumor samples will be examined to evaluate the effects of treatment. Several blood samples also will be collected during the course of treatment to monitor immune system effects. A device called a heparin lock may be put in place to avoid multiple needle sticks. ...

Key facts

Study ID

NCT00005655

Run by

National Cancer Institute (NCI)

People needed

39

Starts

2000-04-28

Expected to finish

2017-03-02

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Critically-ill or medically unstable patients.
• History or a presence of brain metastases.
• History of coronary artery disease, angina or myocardial infarction.
• Presence of clinically significant pleural effusion.
• History of malignant hyperthermia are.
• Concurrent or history of autoimmune disease.
• History of congenital or acquired coagulation disorder.
• Patients with a history of ongoing or intermittent bowel obstruction.
• Women who are pregnant or lactating will be excluded.
• Systemic corticosteroids, radiotherapy, chemotherapy, or other investigational agents within 4 weeks prior to study entry.
• Patients who have received any of the following agents with known immunomodulatory effects within 4 weeks prior to study entry: G-CSF/GM-CSF, interferons or interleukins, growth hormone, IVIG, retinoic acid.
• Patients with a history of previous therapy with rhIL-12 will be excluded from study participation. For patients with renal cell carcinoma, a history of therapy with rhIL-2 will not exclude patients from study participation.
• Patients with concurrent administration of any other investigational agent.
• Patients with hematologic malignancies including leukemia or lymphoma.
• History of bone marrow or stem-cell transplantation.
• Intercurrent radiation therapy patients will be allowed on study if in the opinion of the principal investigator(s) its use is not necessitated by disease progression. For patients with disease progression, radiation therapy will be administered as clinically indicated and the patient will be withdrawn from study participation.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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