QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have metastatic melanoma that is considered surgically incurable. The anti-tumor responses of ALT-801 with cisplatin will also be assessed in this trial.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Altor BioScience; Altor Bioscience Corporation
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Interleukin-2

Criteria

ENTRY CRITERIA:

DISEASE CHARACTERISTICS:

• Locally advanced or metastatic melanoma

• Measurable

• Histologically or cytologically confirmed

• Surgically incurable

• HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes

PRIOR/CONCURRENT THERAPY:

• If prior Proleukin treatment, must have had clinical benefit

• No prior systemic cytotoxic chemotherapy for melanoma

• No concurrent radiotherapy, chemotherapy, or other immunotherapy

• More than 4 weeks since prior major radiotherapy

• More than 8 weeks since prior CTLA-4 antagonist immunotherapy

• Not receiving other investigational agents

PATIENT CHARACTERISTICS:

Life expectancy

• > 3 months

Performance status

• ECOG 0 or 1

Bone marrow reserve

• Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL

• Platelets ≥100,000/uL

• Hemoglobin ≥ 10g/dL

Renal function

• Serum creatinine ≤ 1.5 mg/dL

Hepatic function

• Total bilirubin ≤ 1.5 X ULN

• AST ≤ 2.5 X ULN

• Alkaline phosphatase ≤ 2.5 X ULN

• PT INR ≤ 1.5 X ULN

• aPTT ≤ 1.5 X ULN

Cardiovascular

• May be safely tapered off anti-hypertensives if currently on anti-hypertensives

• New York Heart Association classification I or II

• No congestive heart failure <6 months

• No unstable angina pectoris <6 months

• No myocardial infarction <6 months

• No history of ventricular arrhythmias

• Normal cardiac stress test required if any of the following is present:

• Age ≥ 50

• History of abnormal EKG

• Symptoms of cardiac ischemia or arrhythmia

Pulmonary

• Normal pulmonary function test (FEV1 ≥ 70% of predicted value) if any of the following is present:

• Prolonged history of cigarette smoking

• Symptoms of respiratory dysfunction

Other

• No known autoimmune disease

• No known HIV positive

• No psychiatric illness/social situations that would limit study compliance

• No history or evidence of CNS disease

• No active systemic infection requiring parental antibiotic therapy

• No systemic steroid therapy required

• No prior organ allograft or allogeneic transplantation

• Not receiving chronic medication for asthma

• Not pregnant or nursing

• Fertile patients must use effective contraception