Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: ABI-007; Ipilimumab; Phone Call
Intervention description: Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.; 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.; Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 12 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Melanoma; Metastatic Melanoma; Advanced stage IV melanoma; Unresectable stage III mucosal melanoma; Cutaneous melanoma; Progression-free survival; (PFS); ABI-007; Nab-paclitaxel; Paclitaxel; Abraxane; Ipilimumab; Yervoy; BMS-734016; MDX010

Summary:

      The goal of this clinical research study is to learn if the combination of ipilimumab and
      ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug
      combination will also be studied.

      Ipilimumab is designed to increase the immune system's ability to fight cancer.

      Abraxane is designed to stop cancer cells from making new DNA (the genetic material of
      cells). This may stop the cancer cells from dividing into new cells.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histologically documented diagnosis of advanced stage IV or unresectable
             stage III mucosal or cutaneous melanoma are eligible.

          2. They must have recurrent melanoma with measurable or evaluable sites of disease, 1.0
             cm or larger, in order to assess the response to treatment by the immune-related
             response criteria (irRC).

          3. Patients should not have been previously treated with cytotoxic drugs and
             immunotherapeutic agents for unresectable Stage III or Stage IV disease. Prior
             Ipilimumab in metastatic setting is not allowed. Prior therapy may include one line of
             targeted therapy for metastatic disease ie BRAF or MEK inhibitor. At least 3 weeks
             should have passed since the last dose of prior adjuvant interferon therapy and prior
             targeted therapies, and all previous therapy related toxicities should have resolved
             before starting study treatment. Prior adjuvant interferon is permitted. Prior
             cytotoxic therapy in adjuvant or metastatic setting is not allowed. Prior Ipilimumab
             in adjuvant setting is not allowed. Prior adjuvant therapy with targeted therapy
             including but not limited to B-RAF, MEK inhibitors etc. is allowed. Prior palliative
             radiation therapy for metastatic melanoma is permitted provided the patient has
             unirradiated metastatic sites for response evaluation and has fully recovered from its
             toxicity.

          4. Patients between 12 years of age and 70 years of age with an ECOG performance status
             of 0 or 1 will be eligible

          5. They should have normal blood counts with a white blood cell count of more than or
             equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3 and
             a platelet count of more than 100,000/mm^3, Hemoglobin > 9.0 g/dL and have no
             impairment of renal function (serum creatinine less than 1.1 mg/dl for females and
             less than 1.4 mg/dl for males), hepatic function (serum bilirubin level of less than
             1.5 mg/dl, AST and ALT </= 2.5X ULN unless presence of hepatic metastasis in which
             case AST and ALT </= 5X ULN are acceptable. Alk Phos </= 2.5X ULN ) and no evidence of
             significant cardiac or pulmonary dysfunction.

          6. They should have no significant intercurrent illness such as an active infection
             associated with fever lasting more than 24 hours requiring antibiotics, uncontrolled
             psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active GI
             bleeding. Females of child-bearing potential (non-childbearing is defined as greater
             than one year post-menopausal or surgically sterilized) must use acceptable
             contraceptive methods( abstinence, intrauterine device, oral contraceptive or double
             barrier devices) and must have a negative serum or urine pregnancy test within 72
             hours prior to beginning treatment on this trial. Sexually active men must also use
             acceptable contraceptive methods for the duration of time on study and signed informed
             consent .

        Exclusion Criteria:

          1. Patients with metastatic uveal melanoma

          2. Patients with bone metastases only.

          3. Patients with symptomatic brain or spinal cord metastases or requiring steroid therapy
             and patients with leptomeningeal disease. Patients with treated and stable CNS
             metastasis for 3 months or more, off steroids are eligible for the study. No major
             surgery or radiation therapy within 21 days before starting treatment.

          4. Patients with significant cardiac illness such as symptomatic coronary artery disease
             or previous history of myocardial infarction, impaired left ventricle function
             (Ejection Fraction less than 50%) on account of any organic disease such as
             hypertension or valvular heart disease or serious cardiac arrhythmia requiring
             therapy. Patients with significant history of cardiac disease will be evaluated by the
             investigator or his designee.

          5. Patients with significant impairment of pulmonary function on account of chronic
             bronchitis, emphysema or chronic obstructive pulmonary disease (COPD) which has
             resulted in impairment of vital capacity of FEV1 to less than 75% of predicted normal
             values.

          6. Patients with symptomatic effusions on account of pleural, pericardial or peritoneal
             metastases of melanoma.

          7. Patients who are unable to return for follow-up visits as required by this study.
             Patients with a history of second malignant tumor, other than the common skin cancers
             - basal and squamous carcinomas, within the past 3 years and uncertainty about the
             histological nature of the metastatic lesions. Cases with other types of malignancies
             should be reviewed and decided by the PI of the study.

          8. Patients with ≥ grade 2 sensory neuropathy at baseline.

          9. Patients who have had major surgery or radiation therapy within 21 days of starting
             treatment.