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Investigator(s):
John E. Janik, M.D. Principal Investigator Phone: 301-402-2913 janikj@mail.nih.gov
Referral Contact(s):
Guinevere Chun, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-451-7868 Fax: 301-402-1001 gchun@mail.nih.gov	Suzanne Fioravanti, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-594-6544 Fax: 301-402-1001 fioravas@mail.nih.gov

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Primary Eligibility:

• Pathologically or cytologically-proven diagnosis of solid tumors with radiographically or clinically evaluable disease and for which no other treatment option exists:
• Renal
• Must have had or refused prior treatment with sunitinib or sorefinib
• Breast
• Lung
• Sarcoma
• No history or active CNS involvement
• ≥ 18 years of age
• ECOG performance status of 0 or 1
• Patients must not have received myelosuppressive chemotherapy, hormonal therapy, radiotherapy, or immunotherapy within four weeks of entry onto this protocol
• No prior treatment with IL-12; renal cell patients previously treated with IL-12 allowed
• No prior bone marrow or stem cell transplant
• Must have recovered from all prior therapy
• Adequate hepatic and renal function as evidenced by: transaminases < 2.5 x the upper limit of normal (ULN); total serum bilirubin < 2.0 mg/dL; serum creatinine < 2.0 mg/dL or calculated creatinine clearance of > 60 ml/min/1.73m²
• Adequate bone marrow function (without growth factor support) as evidenced by: absolute neutrophil count (ANC) > 1500 cells/mm³; platelets > 100,000/mm³
• Normal pulmonary function (as documented by PFTs), and for patients over the age of 50, normal stress thallium testing; normal pulmonary function testing will be defined as a DLCO > 60% of predicted and FEVI > 70% of predicted
• Not pregnant or nursing; fertile patients must use effective contraception during study participation
• No medical illness that will preclude study participation
• Patients must be free of acute infection or other significant systemic illness
• Hepatitis B negative
• HIV negative

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Treatment Plan:

This is a phase I dose escalation study designed to evaluate the safety, tolerance and immunomodulatory activity of rhIL-12/pulse rhIL-2 administered to adults with refractory malignancies. Patients will be sequentially enrolled on escalating doses of rhIL-12 in combination with rhIL-2.

• Patients receive rhIL-2 intravenously every 8 hours x 3 doses on Days 1 and 9 of each cycle
• Patients also received rhIL-12 intravenously on Days 2, 4, 6, 10, 12 and 14
• Subsequent treatment cycle repeats every 36 days

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.

Reviewed: 6/18/08
Updated: 8/29/08