Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Temporarily closed 18 and over NCI, Other H2007-0087 CO05601, NCT00590824

Trial Description

Summary

Evaluate the antitumor activity of cilengitide and hu14.18-IL2 alone and in combination in the minimal residual disease setting. Evaluate the time to recurrence and overall survival of patients treated with cilengitide and/or hu14.18-IL2.

Eligibility Criteria

Inclusion Criteria:

• Biopsy proven recurrent stage III or stage IV malignant melanoma that has not yet been excised. (Must involve 3 or fewer sites or be determined to be completely resectable with uninvolved margins using standard surgical guidelines based on physical exam and radiographic imaging of the head, chest, abdomen, and pelvis.)

• Either stage III melanoma with recurrence after prior adjuvant interferon or Stage IV melanoma

• ≥18 years of age and at least 50kg.

• ECOG performance status of 0 or 1.

• Willing to have central venous line placed

• Adequate bone marrow, liver, and renal function

• Have no immediate requirements for palliative chemotherapy, radiotherapy, or hormonal therapy.

• Must be willing and able to discontinue antihypertensive medications if advised to do so for days of hu14.18-IL2 infusion.

• Must have slides available from their biopsy confirming recurrent stage III or stage IV melanoma.

• Must not have had mABs during biologic therapy, tumor imagines, purging of autologous marrow/stem cells for re-infusion or for any reason unless serological testing is performed.

• Must not have developed Grade 4 IL-2 related side effects in the past.

• Must not have received any systemic therapy for stage IV disease.

• Must not be pregnant or nursing and must use effective contraception during the treatment period.

• Must not have symptoms of ischemic cardiac disease, congestive heart failure, myocardial infarct within the immediate preceding 6 months and/or uncontrolled cardiac rhythm disturbance. Subjects with cardiac risk factors must complete a stress radionuclide scan with no evidence of myocardial ischemia or heart failure and have normal pulmonary function.

• Must not have significant psychiatric disabilities or seizure disorders.

• Must not have had major surgery within the past 3 weeks.

• Must not have clinically detectable pleural effusions or ascites.

• Must not have organ allografts

• Must not require or be likely to require corticosteroid or other immunosuppressive drugs or have used them within 2 weeks of registration.

• Must not have significant intercurrent illnesses.

• Must not have active infections or active peptide ulcer unless these conditions are corrected or controlled.

• Must not have a history of coagulation disorder associated with bleeding or recurrent thrombotic events.

• Must not have active or inactive brain metastases. A head MRI will be required at baseline to rule out silent metastases.

• Must not have an active second malignancy other than non-melanoma skin cancer.

• Must not be HIV positive, a Hepatitis B carrier, or with clinical evidence of hepatitis.

• Must not have a clinically significant neurological deficit or objective peripheral neuropathy

• Must not have a known hypersensitivity to the study drug, Tween-80 or to human immunoglobulin.

• Must not have a known history of diabetes mellitus that has required systemic therapy within the past 3 months.

• Must not have a legal incapacity or limited legal capacity.

• Must not have bone metastases.

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Paul M Sondel, MD, PhD

Principal Investigator

Mark R Albertini, MD

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00590824
Information obtained from ClinicalTrials.gov on July 16, 2008