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Home > "M" Clinical Trials Conditions > Monoclonal Antibody and Sargramostim in Treating Patients With Metastatic Prostate Cancer  Monoclonal Antibody and Sargramostim in Treating Patients With Metastatic Prostate Cancer
Monoclonal Antibody and Sargramostim in Treating Patients With Metastatic Prostate Cancer
For Condition: stage 4 prostate cancer,recurrent prostate cancer
Status: Recruiting
Sponsor(s): University of California, San Francisco , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining monoclonal antibody with sargramostim in treating patients who have metastaticprostate cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) administered with sargramostim (GM-CSF) in patients with metastatic androgen-independent prostate cancer. - Determine the safety of this regimen in these patients. - Determine the T-cell immunity and T-cell response in patients treated with this regimen. - Determine the pharmacokinetics of MDX-010 in these patients. - Determine the prostate-specific antigen and/or objective responses in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010). Patients receive MDX-010 IV over 90 minutes on day 1 and sargramostim (GM-CSF) subcutaneously on days 1-14. Treatment repeats every 28 days for a total of 4 courses. GM-CSF continues beyond 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of MDX-010 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6-7 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed prostate cancer - Metastatic disease - Progressive disease after prior androgen deprivation as defined by at least 1 of the following criteria: - Patients with measurable disease must have an increase of at least 20% in the sum of the longest diameter of target lesions OR the appearance of 1 or more new lesions - Patients with nonmeasurable disease must have a positive bone scan and a prostate-specific antigen (PSA) level of at least 5 ng/mL, which has risen on at least 2 successive occasions at least 2 weeks apart* - At least 1 PSA level must be obtained at least 4 weeks after flutamide (6 weeks after bicalutamide or nilutamide) NOTE: *An additional PSA level is required if the confirmatory PSA is not greater than the screening PSA - Testosterone no greater than 50 ng/dL - Patients with no prior orchiectomy must continue luteinizing hormone-releasing hormone agonist therapy - No history or radiologic evidence of CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8 g/dL Hepatic - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT and SGPT no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No significant cardiovascular disease - No New York Heart Association class III or IV congestive heart failure - No active angina pectoris - No myocardial infarction within the past 6 months Other - Fertile patients must use effective contraception prior to, during, and for 3 months after study therapy - No history of autoimmune disease including, but not limited to, any of the following: - Systemic lupus erythematosus - Rheumatoid arthritis - Inflammatory bowel disease - No other medical or psychiatric illness that would preclude study participation or giving informed consent - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy (e.g., vaccines or investigational) - No other concurrent colony-stimulating factors Chemotherapy - No prior chemotherapy - No concurrent chemotherapy Endocrine therapy - See Disease Characteristics - At least 4 weeks since prior systemic corticosteroids - At least 4 weeks since other prior hormonal therapy, including megestrol and finasteride - No concurrent systemic steroid therapy except inhaled or topical steroids - No other concurrent hormonal therapy - Hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed Radiotherapy - At least 4 weeks since prior radiotherapy and recovered - More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 and samarium Sm 153 lexidronam pentasodium) - Prior irradiation of a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed - No concurrent palliative radiotherapy Surgery - See Disease Characteristics Other - At least 4 weeks since prior herbal products known to decrease PSA levels (e.g., PC-SPES or saw palmetto)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrianRini, Study Chair, University of California, San Francisco
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Brian Rini 415-353-7095
Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco, California, 94121
United States
Recruiting H. Lawrence 415-379-5615
Additional Information:
Study ID Numbers: CDR0000309054; UCSF-02558,NCI-6032
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064129
Other Stage 4 Prostate Cancer Studies:
1. Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
2. ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
3. Hormone Therapy in Treating Patients With Prostate Cancer
4. Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
5. Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Monoclonal Antibody and Sargramostim in Treating Patients With Metastatic Prostate Cancer
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