Trial Search Results

Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: Ipilimumab
  • Other: Laboratory Biomarker Analysis
  • Biological: Sargramostim

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - All sites of disease must be evaluated within 4 weeks prior to randomization; patients
   must have measurable disease as defined by Response Evaluation Criteria in Solid
   Tumors (RECIST)

   - No more than one prior systemic therapeutic regimen for unresectable stage III or
   stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or
   investigational treatment; this does not include any therapies given in the adjuvant
   setting

   - Histologic diagnosis of metastatic melanoma; for unknown primary disease, diagnosis of
   metastatic disease by cytology fine needle aspiration (FNA) is not acceptable

   - Women must not be pregnant or breast-feeding; all women of childbearing potential must
   have a blood test within 72 hours prior to randomization to rule out pregnancy; women
   of childbearing potential and sexually active males must be strongly advised to use an
   accepted and effective method of contraception; women of childbearing potential
   (WOCBP) must be using an adequate method of contraception to avoid pregnancy
   throughout the study and for up to 12 weeks after the last dose of investigational
   product, in such a manner that the risk of pregnancy is minimized; sexually mature
   females who have not undergone a hysterectomy or who have not been postmenopausal
   naturally for at least 24 consecutive months (i.e., who have had menses at some time
   in the preceding 24 consecutive months) are considered to be of childbearing
   potential; women who are using oral contraceptives, other hormonal contraceptives
   (vaginal products, skin patches, or implanted or injectable products), or mechanical
   products such as an intrauterine device or barrier methods (diaphragm, condoms,
   spermicides) to prevent pregnancy, or are practicing abstinence or where their partner
   is sterile (e.g., vasectomy) should be considered to be of childbearing potential

   - White blood cells (WBC) >= 2000/uL

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

   - Platelets >= 100,000/mcL

   - Hemoglobin >= 8 g/dL

   - Creatinine =< 3.0 x upper limit of normal (ULN)

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

   - Bilirubin =< 3.0 x ULN, (except patients with Gilbert's syndrome, who must have a
   total bilirubin less than 3.0 mg/dL)

   - No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or
   other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive
   agents; other investigation therapies; or chronic use of systemic corticosteroids;
   must have been discontinued >= 4 weeks

   - No infection with human immunodeficiency virus (HIV)

   - No active infection with hepatitis B

   - No active or chronic infection with hepatitis C

   - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

   - Patients with any history of central nervous system (CNS) metastases are excluded

   - Patients are excluded if they have a history of any other malignancy from which the
   patient has been disease-free for less than 2 years, with the exception of adequately
   treated and cured basal or squamous cell skin cancer, superficial bladder cancer or
   carcinoma in situ of the cervix

   - Patients are excluded if they have a history of any autoimmune disease; patients with
   a history of autoimmune thyroiditis are eligible if their current thyroid disorder is
   treated and stable with replacement or other medical therapy

   - Patients are excluded for 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 adverse events, such as a condition associated with
   frequent diarrhea

   - Patients are excluded for receiving any non-oncology vaccine therapy used for
   prevention of infectious diseases for up to four weeks (28 days) prior to or after any
   dose of ipilimumab

   - Patients are excluded if they have a history of prior treatment with ipilimumab or
   prior cluster of differentiation (CD)137 agonist or cytotoxic T-lymphocyte antigen 4
   (CTLA-4) inhibitor or agonist

   - Any concurrent medical condition requiring the use of systemic steroids is not
   permitted (the use of inhaled or topical steroids is permitted)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting