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A Phase II Study of Ipilimumab PLUS Androgen Deprivation Therapy in Castrate Sensitive Prostate Carcinoma


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

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Trial Information

A Phase II Study of Ipilimumab PLUS Androgen Deprivation Therapy in Castrate Sensitive Prostate Carcinoma


The Study Drugs:

Ipilimumab is designed to block the activity of cells that decrease the immune system's
ability to fight cancer.

Leuprolide, goserelin, and degarelix are designed to help stop the body from making
testosterone (a male sex hormone that prostate cancer cells need to survive), which 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 either
leuprolide, goserelin or degarelix . The drug you receive will depend on what the doctor
thinks is in your best interest and/or which drug your insurance provider will help to
cover. Leuprolide is given through a needle in the muscle. Goserelin and degarelix are
given through a needle under the skin in the abdomen. Beginning at Week 1, you will receive
the drug 1 time every month or every 3 months for up to 8 months. Your doctor will tell you
more about which dosing schedule you will use.

You will also receive ipilimumab by vein over about 90 minutes at Weeks 5, 9, 13, and 17.
Your blood pressure will be measured every 30 minutes during the infusion, as well as an
hour after you are finished receiving the drug.

Study Visits:

Before each dose of ipilimumab, and every 4 weeks for 6 months after the last dose of
ipilimumab, and every 12 weeks after that, the following tests and procedures will be
performed:

- You will have a physical exam.

- You will be asked about any other drugs and/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 3 teaspoons) will be drawn for routine tests and to measure your protein,
PSA, and testosterone levels, and to check the function of your pancreas, thyroid, and
adrenal glands.

- Urine will be collected for routine tests.

- This blood will also be tested for other hormone levels to check the function of your
thyroid and adrenal glands (before each dose of ipilimumab and 4 weeks after the last
dose only).

Every 12 weeks, you will have the same imaging scans that you had at screening.

Length of Study:

You may receive the study drugs for up to 8 months. You will remain on study for as long as
the disease remains stable. You will be taken off study treatment if you have intolerable
side effects or if the disease gets worse.

End-of-Study Treatment/Observation Visit:

Within 14 days after your disease gets worse, the following tests and procedures will be
performed:

- You will have a physical exam.

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

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

- Blood (about 3 teaspoons) will be drawn for routine tests. This blood will also be
tested to measure your protein, PSA, and testosterone levels, and to check the function
of your pancreas, thyroid, and adrenal glands.

- You will have the same imaging scans that you had at screening.

Long-Term Follow-Up:

A member of the study staff will check up on you about every 6 months after your
End-of-Study Treatment/Observation Visit. This will consist of a phone call, an e-mail, or a
review of your medical and/or other records. If you are contacted by phone, the call will
only last a few minutes.

This is an investigational study. Leuprolide, goserelin, and degarelix are FDA approved and
commercially available for the treatment of prostate cancer. Ipilimumab is FDA approved and
commercially available for melanoma. Its use to treat prostate cancer is investigational.

Up to 48 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Histologically or cytologically confirmed prostate carcinoma.

2. Evidence of metastatic disease on previous bone scan and/or CT scan and/or MRI.

3. Castrate-sensitive disease. Patients already on ADT are eligible as long as the time
from initiation of LHRH analog or antagonist is not greater than 1 month AND the
total exposure time to the LHRH analog or antagonist will not exceed 8 months (i.e.
the effectiveness of current depot LHRH analog or antagonist does not extend beyond 8
months since its initiation).

4. Patients who have received prior hormonal therapy are allowed to participate as long
as they have been off hormone ablation for 1.5 times as long as they were on it: e.g.
1) Patients who have received up to 4 months of hormonal ablation are eligible as
long as they have been off hormonal ablation for >/= 6 months; 2) Patients who have
received 1 year of hormonal ablation are eligible as long as they have been off
hormone ablation for >/= 18 months; 3) Patients who have received up to 2 years of
hormonal ablation are eligible as long as they have been off hormonal ablation for
>/= 3 years have elapsed since its discontinuation.

5. ECOG performance status
6. Patients must have normal organ and marrow function as defined below: a) WBC >/=
3000/uL; b) ANC >/= 1500/uL; c) Platelets >/= 100 x 10^3/uL; d) Hemoglobin >/= 9
g/dL; e) Creatinine metastases. For patients with liver metastasis ALT Bilirubin total bilirubin
7. Patients included in the study must be >/= 18 years old

8. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Autoimmune disease: Patients with a history of inflammatory bowel disease (including
Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid
arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus
or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this
study.

2. Any underlying medical or psychiatric condition, which in the opinion of the
Investigator, will make the administration of study drug hazardous or obscure the
interpretation of AEs: e.g. a condition associated with frequent diarrhea or chronic
skin conditions, recent surgery or colonic biopsy from which the patient has not
recovered, or partial endocrine organ deficiencies.

3. Patients with known brain metastases.

4. Patients with small cell carcinoma of the prostate.

5. History of other malignancies, other than nonmelanoma skin cancer or Ta or T1 (low
grade) bladder carcinomas, unless in complete remission and off therapy for that
disease for at least 5 years.

6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, history of congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

7. Known HIV, Hepatitis B, or Hepatitis C.

8. Untreated symptomatic spinal cord compressions.

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

10. 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).

11. Previous participation in another ipilimumab clinical trial or prior treatment with a
CD137 agonist or CTLA-4 inhibitor or agonist.

12. History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal
carcinomatosis or other known risk factors for bowel perforation.

13. Patients who do not agree to practice appropriate birth control methods while on
therapy.

14. Concurrent use of 5-alpha reductase inhibitors (finasteride or dutasteride).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of Participants achieving a PSA ≤ 0.2ng/mL at Month 7

Outcome Description:

Prostate-specific antigen (PSA) conducted by the Simon's optimal two-stage design (Simon, 1989). Antitumor activity assessed through serial PSA measurements (blood tests) at pre-determined time points.

Outcome Time Frame:

Baseline to 7 months

Safety Issue:

Yes

Principal Investigator

Ana M. Aparicio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2009-0378

NCT ID:

NCT01377389

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Castrate sensitive prostate carcinoma
  • Metastatic prostate carcinoma
  • Androgen deprivation therapy
  • ADT
  • Prostate-specific antigen
  • PSA
  • Ipilimumab
  • Yervoy
  • BMS-734016
  • MDX010
  • Leuprolide
  • Lupron Depot
  • Leuprolide Acetate
  • Goserelin
  • Zoladex
  • Degarelix
  • Firmagon
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030