A Phase I Study And Pharmacokinetics Of Adenosine 5'- Triphosphate (ATP) When Administered By Intravenous Infusion On A Multiple Weekly Dose Schedule To Patients With Advanced Malignancies (Solid Tumors)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed advanced solid tumor that is not curable by
conventional therapy

- Brain metastases allowed if adequately controlled with radiotherapy

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 12 weeks

Hematopoietic:

- WBC at least 3,500/mm^3

- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- SGOT and SGPT no greater than 3 times normal

- Bilirubin no greater than 2.0 mg/dL

Renal:

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance greater than 60 mL/min

- BUN no greater than 25 mg/dL

Cardiovascular:

- Adequate cardiovascular function

- No congestive heart failure (New York Heart Association class III or IV heart
disease)

- No angina pectoris AND/OR

- No significant arrhythmia

- No myocardial infarction within the past 6 months

- No clinically significant ischemic cardiac disease currently under treatment

- No clinically significant conduction system disease in the absence of a pacemaker
(e.g., sick sinus syndrome, or second or third degree atrioventricular block)

Pulmonary:

- Adequate pulmonary function

- No clinical evidence of acute chronic obstructive pulmonary disease

- FEV1 at least 50% predicted

- Arterial oxygen tension at least 90% by pulse oximetry and on breathing room air

- No asthma OR

- No evidence of more than 20% reversibility in FEV1 with albuterol therapy

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No history of severe adverse reaction to adenosine

- No uncontrolled medical illness

- No average daily pain scores of at least 5 on a simple Visual Analogue Self pain
assessment (0-10) scale

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- At least 30 days since prior investigational therapy

- At least 14 days since prior long-term theophylline, dipyridamole, or
dipyridamole/aspirin therapy

- No concurrent long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy

- No concurrent maintenance anti-anginal drug therapy