A Phase Ib/II Trial of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer

Inclusion Criteria

ENTRY CRITERIA:

DISEASE CHARATERISTICS:

- Muscle invasive or metastatic urothelial cancer of bladder, ureters, renal pelvis,
and urethra

- Histologically or cytologically confirmed with a clinical plan that would potentially
include cisplatin* plus gemcitabine systemic therapy or with disease refractory to a
first-line platinum-based therapy (as defined in the protocol).

* Does not apply to patients screened for Phase II expansion

- Surgically incurable

PRIOR/CONCURRENT THERAPY:

- No concurrent radiotherapy, other chemotherapy, or other immunotherapy

- Must have recovered from side effects of prior treatments

- If prior Proleukin® treatment, must have had a clinical benefit

- No use of other investigational agents within 30 days of start or concurrently

PATIENT CHARACTERISTICS:

Age

- ≥ 18 years

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

- Glomerular Filtration Rate (GFR):

- ≥ 50mL/min/1.73m^2 for cisplatin-containing regimen

- ≥ 40mL/min/1.73m^2 for non-cisplatin-containing regimen

Hepatic Function

- Total bilirubin ≤ 1.5 X ULN

- AST, ALT, ALP ≤ 2.5 X ULN, or ≤ 5.0 X ULN (if liver metastases exists)

- PT INR ≤ 1.5 X ULN

Cardiovascular

- No congestive heart failure < 6 months

- No unstable angina pectoris < 6 months

- No myocardial infarction < 6 months

- No history of ventricular arrhythmias

- No NYHA Class > II CHF

- Normal cardiac stress test required for subjects who are ≥ 50 years old, or have a
history of EKG abnormalities, or have symptoms of cardiac ischemia or arrhythmia

- No uncontrolled hypertension

Pulmonary

- Not receiving chronic medication for asthma

- Normal clinical assessment of pulmonary function

Hematologic

- No evidence of bleeding diathesis or coagulopathy

Other

- Negative serum pregnancy test if female and of childbearing potential

- No women who are pregnant or nursing

- Subjects, both females and males, with reproductive potential must agree to use
effective contraceptive measures for the duration of the study

- No known autoimmune disease other than corrected hypothyroidism

- No known prior organ allograft or allogeneic transplantation

- Not HIV positive

- No active systemic infection requiring parenteral antibiotic therapy

- No ongoing systemic steroid therapy required

- No history or evidence of CNS disease (Controlled brain metastases treated with
radiation therapy or surgery where the disease has been clinically stable for a
period of a least 3 months before screening is allowed)

- No psychiatric illness/social situation

- No other illness that in the opinion of the investigator would exclude the subject
from participating in the study

- Must provide informed consent and HIPAA authorization and agree to comply with all
protocol-specified procedures and follow-up evaluations