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

TerminatedPhase 1, Phase 2

Sponsor: Altor BioScience

Conditions: Metastatic Melanoma

Interventions: Cisplatin, ALT-801

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (8)

Los Angeles, California, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Charlotte, North Carolina, United States
Bethlehem, Pennsylvania, United States
Seattle, Washington, United States