A Phase I Safety Study Of Xcellerate In Patients With Hormone Refractory Prostate Cancer
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Evidence of androgen-independent disease
- Patient must have received prior primary hormonal therapy (e.g.,
orchiectomy or gonadotropin-releasing hormone analog with or without
antiandrogen)
- Demonstrated disease progression by any 1 of the following:
- Elevated PSA level (at least 5 ng/mL) that has serially risen from
baseline on 2 occasions at least 1 week apart
- At least 1 new osseous lesion on bone scan
- More than 25% increase in the sum of the products of the perpendicular
diameters of all bidimensionally measurable sites of disease
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- ECOG 0-1
Life expectancy:
- At least 3 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGPT no greater than 1.5 times ULN
- Hepatitis B surface antigen negative
- No active or chronic hepatitis B or C
- No other hepatic dysfunction that would preclude study
Renal:
- Creatinine less than 2.0 mg/dL
- Calcium less than 11 mg/dL
- No renal dysfunction that would preclude study
- No symptomatic hypercalcemia
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Pulmonary:
- No pulmonary disease requiring inhaled steroids or bronchodilators
Other:
- No history of HIV 1 or 2 or human T-cell lymphotrophic virus (HTLV) 1 or 2
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer
- No history of autoimmune disease (e.g., rheumatoid arthritis or multiple sclerosis)
- No other major organ system dysfunction
- No gastrointestinal, neurologic, or psychiatric dysfunction that would preclude study
- Human anti-mouse antibody negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent growth factors, interleukin, interferons, or cytokines
Chemotherapy:
- No prior chemotherapy or other systemic chemotherapy agent for prostate or any other
cancer
Endocrine therapy:
- Prior aminoglutethimide allowed
- At least 4 weeks since prior flutamide
- At least 6 weeks since prior bicalutamide or nilutamide
- Concurrent luteinizing hormone-releasing hormone agonists should be continued
- No concurrent corticosteroids or dexamethasone
- No concurrent anti-androgens (e.g., flutamide, bicalutamide, or nilutamide)
Radiotherapy:
- At least 4 weeks since prior local radiotherapy
- No prior radiopharmaceutical therapy (e.g., strontium chloride Sr 89 or samarium Sm
153 lexidronam pentasodium)
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- Prior ketoconazole or PC-SPES allowed
- At least 1 week since prior antibiotic, antifungal, or antiviral agents
- At least 4 weeks since other prior systemic therapy for prostate cancer (except
bisphosphonates or hormonal therapy)
- At least 6 weeks since prior investigational drugs or devices
- No other concurrent therapy for this disease
- No concurrent participation in another clinical trial
- No concurrent bisphosphonates unless initiated prior to study
- No concurrent immunosuppressive drugs
- No other concurrent experimental therapies