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A Neoadjuvant Phase IIa Study of Ipilimumab {Formerly Known as MDX-010 (BMS-734016)} Plus Hormone Ablation in Men With Prostate Cancer Followed by Radical Prostatectomy.


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Neoadjuvant Phase IIa Study of Ipilimumab {Formerly Known as MDX-010 (BMS-734016)} Plus Hormone Ablation in Men With Prostate Cancer Followed by Radical Prostatectomy.


The Study Drugs:

Ipilimumab is designed to cause an immune response in your body by blocking 2 specific
molecules that usually block an immune response. This may help to kill cancer cells.

Leuprolide acetate is designed to lower the level of testosterone (a male hormone) in the
blood. This may slow the growth of cancer cells.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive a leuprolide
acetate injection in your muscle. This is considered Week 0. One week later, you will begin
treatment with ipilimumab. Ipilimumab will be given by vein over 90 minutes during Weeks 1
and 4 (about 21 days apart). During the infusion, your blood pressure will be measured every
30 minutes, and again an hour after you are finished receiving the drug.

Study Visits:

At Weeks 0, 1, 4 and 7, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs and weight.

- You will be asked about any drugs or treatments you may be receiving.

- You will be asked about any side effects you may have experienced.

- Your performance status will be recorded.

- Blood (about 7-10 tablespoons) will be drawn for routine tests. This blood will also
be tested to measure your protein, PSA and testosterone levels, to check the function
of your thyroid and adrenal glands, and to test for an immune response.

Surgery:

About 4 weeks after your second treatment with ipilimumab, you will have surgery to remove
your prostate gland. You will be asked to sign a separate consent form that describes the
surgery and its risks. A sample of the leftover prostate gland tissue from surgery will be
tested for an immune response. On that day, the following tests and procedures will be
performed:

Between 14 and 24 weeks after your surgery, you will return to the clinic for your
post-operative follow-up visit. The following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs and weight.

- Your performance status will be recorded.

- You will be asked about any drugs or treatments you may be receiving.

- You will be asked about any side effects you have experienced since your last visit.

- Blood (about 7-10 tablespoons) will be drawn for routine tests. This blood will also
be used to measure your protein, testosterone and PSA levels, to check the function of
your thyroid and adrenal glands, and to test for an immune response.

- You will have a bone scan, and either a CT or MRI scan of your chest, abdomen, and
pelvis to check the status of the disease.

Length of Study:

You will only receive 2 treatments with ipilimumab on this study. You will be on study until
24 weeks after surgery. You will be taken off study if intolerable side effects occur, if
the disease gets worse, or if the study doctor thinks it is in your best interest to be
taken off study.

This is an investigational study. Ipilimumab is not FDA approved or commercially available.
Ipilimumab is currently being used for research purposes only. Leuprolide acetate is FDA
approved for management of metastatic prostate cancer but is not approved for use before
definitive surgery. It is commercially available to treat prostate cancer.

Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Willing and able to give written informed consent;

2. Histologic Documentation: Histologic documentation of prostatic adenocarcinoma.
Patients with small cell, neuroendocrine, or transitional cell carcinomas are not
eligible. All eligible patients must have a known Gleason sum based on biopsy or TURP
at the time of registration.

3. Locally Resectable Disease: Patients must have disease (localized or locally
advanced) which is deemed by the surgeon to be resectable. Lymph node metastasis or
lymph nodes suspicious of harboring metastasis should be deemed surgically resectable
by the surgeon.

4. Determination of high-risk status: Patients must have either: 1) a Prostate biopsy
Gleason sum >/= 8 OR 2) PSA >/= 20.

5. Prior Treatment: No prior treatment for prostate cancer including prior surgery
(excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy.
Patients who have initiated leuprolide acetate within 1 week of signing consent will
be eligible.

6. Patients must be appropriate candidates for radical prostatectomy. Evidence of
underlying cardiac disease should be evaluated prior to enrollment to ensure that
patients are not at high risk of cardiac complications.

7. ECOG performance status of 0 or 1;

8. Required values for initial laboratory tests: a) WBC >/= 3000/uL; b) ANC >/= 1500/uL,
c) Platelets >/= 100 x 10^3/uL; d) Hemoglobin >/= 9 g/dL; e) Creatinine ULN; f) AST Syndrome, who must have a total bilirubin less than 3.0 mg/mL;

9. Men >/= 18 years of age

10. Patients must agree to practice barrier birth control methods while on therapy, prior
to surgery.

Exclusion Criteria:

1. Any other malignancy from which the patient has been disease-free for less than 5
years, with the exception of adequately treated and cured basal or squamous cell skin
cancer.

2. Autoimmune disease: Patients with a history of Inflammatory Bowel Disease (including
Crohn's disease and ulcerative colitis) are excluded from this study as are patients
with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic
progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune
vasculitis [e.g., Wegener's Granulomatosis]).

3. Known HIV or chronic hepatitis.

4. Any underlying medical condition, which in the opinion of the Investigator, will make
the administration of study drug hazardous or obscure the interpretation of adverse
events, such as a condition associated with frequent diarrhea.

5. Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI
obstruction, abdominal carcinomatosis which are known risks factors for bowel
perforation, should be excluded from the study.

6. Any non-oncology vaccine therapy used for prevention of infectious diseases (for up
to one month prior to or after any dose of ipilimumab.

7. Concomitant therapy with any of the following: IL-2, interferon or other non-study
immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other
investigation therapies; or chronic use of systemic corticosteroids (used in the
management of cancer or non-cancer-related illnesses);

8. Previous treatment with other investigational products within 30 days;

9. Previous enrollment in another MDX-010 (BMS-734016) clinical trial or prior treatment
with a CD137 agonist or CTLA-4 inhibitor or agonist

10. Concurrent use of 5-alpha-reductase inhibitors (finasteride, dutasteride).

11. Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled in this study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Longitudinal Peripheral Blood Values

Outcome Description:

Five immunological variables measured on peripheral blood (pb) samples and tumor tissue samples: (i) effector to regulatory T cell ratio (measured in blood and tumor), (ii) CD4+ICOS+ T cells (measured in blood and tumor), (iii) CD8+ICOS+ T cells (measured in blood and tumor), (iv) NY-ESO-1 antibodies (measured only in blood, not tumor), and (v) absolute lymphocyte count (measured only in blood, not tumor). Measurements based on pb samples weeks 0, 1, 4, 7, and measurements from tumor tissue at week 8.

Outcome Time Frame:

Weekly for 8 weeks

Safety Issue:

Yes

Principal Investigator

Padmanee Sharma, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2009-0135

NCT ID:

NCT01194271

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Hormone Ablation
  • Prostate adenocarcinoma
  • Radical prostatectomy
  • Leuprolide Acetate
  • Lupron Depot
  • Ipilimumab
  • BMS-734016
  • MDX010
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030