Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

Trial end date:
Target enrollment:
Participant gender:
This phase I trial is studying the side effects and best dose of temsirolimus when given together with hormone therapy in treating patients with relapsed prostate cancer. Androgens can cause the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by lowering the amount of androgens the body makes. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hormone therapy together with temsirolimus may kill more tumor cells
Phase 1
Accepts Healthy Volunteers?
Lead Sponsor:
National Cancer Institute (NCI)
Inclusion Criteria:

- All patients must sign an informed consent indicating that they are aware of the
investigational nature of this study; patients must also have signed an authorization
for the release of their protected health information

- Patients must have histologically confirmed adenocarcinoma of the prostate recurring
after local therapy (radical prostatectomy and/or radiation therapy) as evidenced by
rising serum PSA

- Prostate-Specific Antigen (PSA) Doubling Time (PSADT) =< 12 months after local therapy
(prostatectomy and/or definitive radiation) as determined by linear regression of all
available PSA values within 6 months of initiation of androgen ablation (for patients
who underwent prostatectomy, at least one PSA measurement of >= 1.0 ng/mL; for
patients who underwent radiation, at least one PSA measurement of >= 3.0 ng/mL and >=
150% postradiation nadir)

- No evidence of metastasis as determined by bone scan or computed tomography (CT) scan

- Initiation of Androgen Ablation of less than 8 weeks' duration prior to study entry is

- Leukocytes ≥ 3,000/mcl

- Absolute neutrophil count ≥ 1,000/mcl

- Hemoglobin ≥ 8.0g/dl

- Eligibility level for hemoglobin may be reached by transfusion

- Platelet count >= 100,000/μL

- Total bilirubin ≤1.5 X laboratory ULN

- AST and/or ALT ≤ 3 X laboratory ULN

- Creatinine ≤ 1.5 X laboratory ULN OR calculated creatinine clearance ≥ 60 ml/min/1.73
m^2 for patients w/creatinine levels above the laboratory ULN

- Serum cholesterol level < 350 mg/dl

- Triglyceride level < 300mg/dl

- ECOG performance status 0, 1 or 2

- The effects of Temsirolimus on the developing human fetus are unknown; for this reason
men must agree to use contraception from the time of study enrollment continuing for
the duration of study participation

- Patients must be registered in the MDACC institutional database prior to treatment
with study drug

- PSA < 40 ng/ml

Exclusion Criteria:

- Patients with histologic variants other than adenocarcinoma in the primary tumor

- Patients may not be receiving any other investigational agents

- Patients may not be receiving concomitant immunotherapy or immunosuppressive therapy

- Patients may not have received prior systemic treatment for prostate cancer (other
than no more than 3 months of prior treatment with androgen ablation in neoadjuvant
and/or adjuvant setting and at least a year must have elapsed since last
administration) unless initiation of Androgen Ablation of less than 8 weeks' duration
prior to study entry is permitted

- Patient with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection requiring parenteral therapy on day 1 of protocol treatment,
symptomatic congestive heart failure resulting in a resting O2 saturation of < 92% on
room air, unstable angina pectoris, myocardial infarction within the previous 6
months, or use of ongoing maintenance therapy for life-threatening ventricular
arrhythmia, known pulmonary hypertension or pneumonitis

- Patients in a severely compromised immunological state, including being positive for
the human immunodeficiency virus (HIV) due to possible pharmacokinetic interactions
with HAART therapy

- Patients diagnosed with acute or chronic hepatitis B or C

- Patients using immunosuppressive agents, including intravenous corticosteroids, within
3 weeks of study entry

- Patients must not have a history of any other cancer (except nonmelanoma skin cancer),
unless in complete remission and off of all therapy for that disease for a minimum of
3 years