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CYT107 With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Complete title: A Phase 2 Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) after Completion of Standard FDA Approved therapy with Sipuleucel-T (Provenge®) for Patients with Asymptomatic or Minimally Symptomatic Metastatic Castration-resistant Prostate Cancer (mCRPC)

Research Study Number       8037A
Principal Investigator       Evan Yu, MD
Phase       II

Look up trial at NIH

Research Study Description

This randomized phase II trial studies how well glycosylated recombinant human interleukin-7 (CYT107) with or without vaccine therapy works in treating patients with hormone-resistant prostate cancer that has spread to other areas of the body or has not responded to at least one type of treatment. Biological therapies, such as glycosylated recombinant human interleukin-7, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. It is not yet known whether glycosylated recombinant human interleukin-7 works better with or without vaccine therapy in treating prostate cancer.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Male

- Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC)

- Patients must have successfully completed therapy with sipuleucel-T within 3-7 days of planned CYT107 study drug treatment

- Assessable disease with a positive bone scan and/or measurable disease on computed tomography (CT) scan and/or magnetic resonance imaging (MRI) of the abdomen and pelvis

- Prior orchiectomy or must be on ongoing luteinizing hormone-releasing hormone (LHRH) agonist or antagonist (e.g., degarelix) therapy

- No ongoing anti-androgen therapy; patients must be off anti-androgen therapy for at least 30 days

- Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease prostate specific antigen (PSA) levels (e.g. Saw Palmetto, PC-SPES), or any systemic corticosteroid, must discontinue the agent for at least 30 days prior to study treatment

- Absolute neutrophil count (ANC) >= 1500/uL

- Bilirubin < 1.5 x upper limit of normal (ULN)

- Hemoglobin >= 10 g/dL

- PSA >= 2 ng/mL

- Platelets >= 100,000/mcL

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN

- Creatinine clearance >= 60 mL/min by the Cockcroft-Gault equation

- Testosterone =< 50 ng/dL (documented at any time while on LHRH agonist or antagonists or s/p orchiectomy)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or a Karnofsky performance status of >= 80%

- Life expectancy of at least 6 months

- Prior local radiation therapy must be completed at least 30 days prior to enrollment and the patient must have recovered from all toxicity

- Prior "systemic" radiopharmaceuticals (strontium, samarium) must be completed >= 8 weeks prior to enrollment

- Patients must agree to use 2 methods of adequate contraception for the duration of study participation, and for four months after discontinuing therapy, because of the unknown potential risk to a gamete and/or developing embryo from this investigational therapy

- Ability to understand and the willingness to sign a written informed consent document

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Prior chemotherapy for prostate cancer, with the exception of neoadjuvant chemotherapy

- Prior investigational immunotherapy

- Prostate cancer pain requiring regularly scheduled narcotics

- Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression

- Current treatment with systemic steroid therapy (inhaled/topical steroids are acceptable); systemic corticosteroids must be discontinued for at least 30 days prior to first CYT107 injection

- Known central nervous system metastases

- Documented cirrhosis or documented acute hepatitis; Note: a positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B (HBV) infection is not an exclusion criterion

- History of severe asthma, as defined by prior or current use of systemic corticosteroids for disease control, with the exception of physiological replacement doses of cortisone acetate or equivalent, as defined by a dose of 10 mg or less

- Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves

- Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)

- Concurrent or prior malignancy except for the following:

-- * Adequately treated basal or squamous cell skin cancer

-- * Adequately treated stage I or II cancer from which the patient is currently in complete remission

-- * Any other cancer from which the patient has been disease-free for 5 years

- Known human immunodeficiency virus (HIV) or other history of immunodeficiency disorder

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness

- Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of CYT107 hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea

- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CYT107

- Patients who have received prior immunosuppressive therapy within 30 days prior to enrollment

- Active (as defined by requiring immunosuppressive therapy) or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy)

- Patients who have received hepatotoxic drugs less than 7 days prior to enrollment

- Patients who have received prior biologic agents less than 30 days prior to enrollment

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

- Patients who have a history of any hematopoietic malignancy

- History of pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD), (forced expiratory volume [FEV] > 60% of predicted for height and age required in patients with prolonged smoking history or symptoms of respiratory dysfunction)

Other exclusion criteria may apply.

Research Study Number       8037A
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Prostate Cancer; Solid Tumors; Urogenital Neoplasms; Genital Neoplasms, Male

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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