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Melanoma Trials
TITLE CASE 1604: Phase II Trial of Interferon-Beta in Patients with Metstatic Cutaneous Melanoma and Metastatic Ocular Melanoma
DESCRIPTION This study will evaluate the effectiveness and side effects of Interferon beta in the treatment of advanced melanoma, a skin cancer. Patients can join the study if they have been recently diagnosed with melanoma, have melanoma that has not responded to treatment, or have melanoma that has returned after treatment. Interferon beta will be given daily by subcutaneous (underneath the skin) injection. 
ELIGIBILITY
  1. Must have a diagnosis of metastatic melanoma with measurable disease
  2. No prior alpha interferon therapy in the past 12 months or for metastatic disease in the past 30 days
  3. Must have an ECOG performance status of 0 or 1
  4. Must have a life expectancy of 3 months
  5. Must have recovered from toxicity of any radiation therapy given in time period exceeding 28 days from the start of treatment 
  6. Must not have had general anesthesia in the 28 days prior to treatment
  7. Must have adequate bone marrow, liver and kidney organ function
  8. Must meet guidelines for treatment of metastatic disease.
CONTACT Lind Rath,  RN – 215-844-7028
TITLE E 2603: A Double-blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and BAY 43-9006 versus Carboplatin, Paclitaxel and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma 
DESCRIPTION

Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and growing. Sorafenib (also known as BAY 43-9006) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether carboplatin and paclitaxel together with sorafenib is more effective than carboplatin and paclitaxel alone (without sorafenib) in treating melanoma. The purpose of this study is to find out if adding sorafenib to the treatment will benefit patients with stage III or stage IV melanoma that has spread or cannot be treated with surgery. Patients will be randomly assigned to one of two treatment groups. In one group, patients will receive paclitaxel and carboplatin. They will also receive sorafenib by mouth. Patients in the other group will receive paclitaxel and carboplatin but this group will also receive a placebo instead of sorafenib. 

ELIGIBILITY
  1. Stage III or Stage IV melanoma not amenable to surgery 
  2. Be at least 18 years of age
  3. Have measurable disease
  4. Have no brain metastasis or other
  5. current malignancies (cancers)
  6. Have no ocular melanoma
  7. Have normal kidney and liver function
CONTACT Lind Rath,  RN – 215-844-7028
TITLE S0331 A Phase II Trial of STI-571/Imatinib (Gleevec) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
DESCRIPTION This study is being done to evaluate the objective response of oral STI-571/imatinib (Gleevec®) given to patients with metastatic or unresectable Merkle cell carcinoma, a neuroendocrine tumor of the skin.  Patients will take STI-571/Imatinib once a day.  Patients will continue taking the drug unless the disease progresses or the patient experiences severe
ELIGIBILITY
  1. Patients must have a biopsy-proven diagnosis of Merkel Cell Carcinoma that is distantly metastatic or unresectable.
  2. Patients with symptomatic, unstable or untreated brain metastases are not eligible.
  3. Patients may not have received radiotherapy, chemotherapy or any other investigational drug for any reason 28 days prior to entry into the study.
  4. Patients may not have had a major surgery within 14 days before entry into the study,
  5. Patients must not have a severe and/or uncontrolled concurrent medical disease such as diabetes, chronic renal or liver disease of active uncontrolled infection.
  6. Patients must not be taking therapeutic dishes of coumadin (warfarin) as anticoagulation at the time of entry into the study.
  7. Patients must have adequate bone marrow, liver and kidney function.
CONTACT Lind Rath,  RN – 215-844-7028
TITLE E 2602: Phase II Study of Low Dose Peginterferon Alfa-2b in Patients with Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
DESCRIPTION This study will determine whether circulating b-FGF level can be suppressed to normal levels with Peginterferon alfa-2b. During the induction phase, patients will receive Peginterferon alfa-2b weekly for approximately 6 weeks. Patients without disease progression will proceed to the maintenance phase and will receive Peginterferon alfa-2b for 12 months.
ELIGIBILITY
  1. Patients must have histologically proven melanoma.
  2. Patients must not have brain metastases.
  3. Patients current disease may be previously untreated or have received up to 2 prior systemic therapies for metastatic disease. 
  4. Prior interferon use adjuvantly or for metastatic disease is permitted. Prior therapy must have been discontinued at least 4 weeks before registration.
  5. Patients must have normal bone marrow, kidney and liver function.
CONTACT Linda Rath, RN 216-844-7028
TITLE E 1697: Randomized Study of Four Weeks High Dose Interferon Alpha 2B in Stage IIA Melanoma
DESCRIPTION The study will compare the effect of treatment with 4 weeks of high dose interferon on the relapse-free survival of patients with resected melanoma and assess the toxicity of high dose interferon.
ELIGIBILITY

 

  1. Melanoma of a cutaneous origin. Initial presentation of primary melanoma.
  2. No clinically palpable lymphadenopathy
  3. Must be one of the following: T3N0M0, T4N0M0, T1-4N1
  4. Must be within 70 days of wide excision and no longer than 84 days after initial biopsy
  5. No evidence of incompletely resected melanoma or any distant metastatic disease
  6. Must not have autoimmune disorders, conditions of immunosuppression or be on systemic corticosteroids
  7. No history of active ischemic heart disease, cerebrovascular disease or congestive heart failure
  8. No prior chemotherapy or immunotherapy
  9. ECOG performance status 0-1 within 8 weeks of randomization
  10. Adequate hematologic and liver function
  11. Must not have any significant medical or surgical condition or require any medication or treatment regimen
CONTACT Linda Rath, RN 216-844-7028
 
TITLE E 4697: A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF versus Peptide Vaccination versus GM-CSF plus Peptide Vaccination versus Placebo in Patients with "No Evidence of Disease" after Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
DESCRIPTION This study will compare overall survival, two-year survival and time to progression of patients with completely resected stage IV melanoma or stage III melanoma with gross extranodal extension, satellites, and/or intransit lesions, treated with GM-CSF vs. no GM-CSF. Patients are divided into HLA-A2 positive and negative groups. A2 positive patients will be randomized to receive one of the following treatments: 1) GM-CSF plus peptide vaccination, 2) GM-CSF placebo plus peptide vaccination, 3) GM-CSF plus peptide placebo, or 4) GM-CSF placebo plus peptide placebo. A2 negative patients will be randomized to receive either GM-CSF or placebo.
ELIGIBILITY

 

  1. Must have completely resected melanoma which falls into one of the following categories: a) cutaneous melanoma with clinically evident satellites or intransit disease, b) stage III melanoma with gross extracapsular extension, c) mucosal melanoma with nodal involvement, or d) stage IV cutaneous, ocular, or mucosal melanoma, e) any locoregional recurrence after prior adjuvant interferon or failure on S0008, f) any local recurrence of disease after adequate surgical excision of the original primary, g) recurrence in a previously resected nodal basin,       h) four or more involved lymph nodes or matted lymph nodes, i) an ulcerated primary melanoma and any involved lymph nodes (Note: a,b,g,h, and i must be ineligible for S0008 or medically unfit to receive standard high dose interferon
  2. Must be within 16 weeks of surgical resection
  3. No prior treatment with GM-CSF or any peptides
  4. ECOG performance status 0-1
  5. No active infection or serious concurrent medical condition
  6. Adequate liver and hematologic function
  7. Patients that have had multiple primary melanomas are eligible
  8. Patients who are eligible for S0008 are strongly encouraged to participate in that study
CONTACT Linda Rath, RN 216-844-7028
 

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