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Lakeland Regional Cancer Center
Lakeland Regional Cancer Center

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Lakeland Regional Cancer Center

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Melanoma

  1. A Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Treatment with 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects with Recurrent Metastatic Melanoma
  2. A Phase II Study of Low DOse Peginterferon Alfa-2B in Patients with Metastatic melanoma Over-Expressing Basic Fibroblast Growth Factor
  3. Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T3-T4 or N1 (Microscopic) Melanoma
  4. A Randomized Phase II Trial of BAY-43-9006 (Sorafenib; NSC-724772) with Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma and Assessment of te Role of PET Imaging for Evaluation as an Early Indicator of Response
  5. A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and Sorafenib Versus Carboplatin, Paclitaxel and Placebo in patients with Unresectable Locally Advanced or Stage IV Melanoma

A Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Treatment with 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects with Recurrent Metastatic Melanoma

Eligibility Criteria (Per Protocol dated 08/29/07):

  1. ECOG Performance status of 0-1.
  2. Histologically confirmed recurrent metastatic melanoma, which may have received primary surgical resection, adjuvant therapy, and/or biotherapy.
  3. At least one injectable lesion (cutaneous, subcutaneous, or nodal lesion) of at least 1 cm and no more than 25 cm. Lesions between 25 cm and 100 cm are not injected, but may be followed as target lesions.
  4. Not eligible if subject has received prior cytotoxic chemotherapy for malignant melanoma.
  5. Not eligible if subject has received prior Allovectin-7 injection(s).
  6. Not eligible if surgery is a curative option.
  7. Not eligible if subject is HIV-positive.
  8. Not eligible if subject has a history of visceral metastasis, M1c, other than lung (M1b not excluded).
  9. Not eligible if subject has other malignancy not currently in remission or unlikely to have been cured with prior therapy (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or low grade prostate cancer.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Phase II Study of Low DOse Peginterferon Alfa-2B in Patients with Metastatic melanoma Over-Expressing Basic Fibroblast Growth Factor

Eligibility Criteria (Per Protocol Addendum #5, dated 08/07):

  1. Histologically proven melanoma.
  2. Subjects with CNS involvement are allowed provided that CNS directed therapy has been given and CNS disease has been clinically stable for 3 months. Brain CT scan or MRI required within at least 4 weeks prior to registration to confirm stable disease.
  3. ECOG Performance status of 0, 1, or 2 at the time of pre-registration.
  4. No history of myocardial infarction within the last 6 months or any concurrent illnesses which in the opinion of the study doctor, would place the subject at increased risk.
  5. No history of severe depression.
  6. No concomitant second active malignancy. Subjects with basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix within the past 5 years must have been treated with curative intent. Subjects with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for at least 5 years.
  7. Subject must have evidence of disease, which may or may not be measurable.
  8. Subject may have been previously untreated or have received up to 3 prior systemic therapies for metastatic disease. Prior radiation therapy (any number) and interferon use adjuvantly or for metastatic disease is permitted. Vaccine therapy will not be counted as systemic therapy. All prior therapies must have been discontinued for more than 4 weeks prior to registration.
  9. Negative pregnancy test is required.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T3-T4 or N1 (Microscopic) Melanoma

Eligiblity Criteria (per Protocol Update #5, dated 05/09):

  1. Only subjects with presentation of melanoma are eligible. Subjects must not have clinically palpable lymphadenectomy. If no regional lymph node basin pathologic staging is done and lymph nodes are not clinically positive, subejcts will also be allowed on study. Subjects with a positive sentinel lymph node should undergo complete lymphadenectomy of the nodal basin.
  2. Subject must not have a history of active ischemic heart disease or cerebrovascular disease or congestive heart failure.
  3. SUbject must not have autoimmune disorders, conditions of immunosuppression or be currently on treatment with systemic corticosteroids, topical steroid creams or ointments, or any steroid containing inhalers.
  4. Subject must complete all primary therapy (wide excision with or without lymphadenectomy) and be randomized within 84 days of their wide excision.
  5. Subject must have either a CXR, PET-CT or chest CT and, if clinically indicated, a CT scan or MRI of the head performed between initial biopsy of melanoma and randomization.
  6. Subject must not have a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude full participation in the protocol.
  7. Subject must not have another significant medical or surgical condition, or require any medication or treatment regimen which may interfere with the completion of this trial or with the evaluation of safety and efficacy of the study drug.
  8. Subject must not have clinically palpable lymphadenectomy.
  9. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

A Randomized Phase II Trial of BAY-43-9006 (Sorafenib; NSC-724772) with Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma and Assessment of te Role of PET Imaging for Evaluation as an Early Indicator of Response

Eligibility Criteria (per Protocol dated 02/15/09):

  1. Subject must have a biopsy-proven diagnosis consistent with malignant melanoma of cutaneous or mucosal origin. Subjects with ocular melanoma are not eligible. Subjects must have unresectable disease. Subjects must have Stage IV disease. Serum LDH must have been measured for sub-stage identification and treatment randomization purposes.
  2. Subject must have measurable disease. All measurable lesions must be assessed (by physical examination, CT or MRI scan, or plain X-ray) within 28 days prior to registration. All non-measurable disease must be assessed within 42 days prior to registration.
  3. Subject must undergo a CT or MRI of the brain which is negative for brain metastases within 42 days prior to registration. Subjects with a history of brain metastases are ineligible regardless of prior therapy and response.
  4. Zubrod Performance status of 0-1.
  5. Subject must not have received any prior systemic therapy for Stage IV disease.
  6. Prior adjuvant therapy is allowed and may include cytotoxic agents, but the interval from most recent exposure to cytotoxic agents until registration must be at least 90 days.
  7. Subject may have received prior radiation therapy. Radiation therapy must have been completed at least 28 days prior to registration.
  8. Subject must not have any evidence of bleeding diathesis or coagulopathy.
  9. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the subject is currently in complete remission, or any other cancer from which the subject has been disease-free for 5 years.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, OCN, CCRC at (863) 904-1877.

A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and Sorafenib Versus Carboplatin, Paclitaxel and Placebo in patients with Unresectable Locally Advanced or Stage IV Melanoma

Eligibility Criteria (Per Protocol dated 02/03/09):

  1. Histological or cytological confirmed melanoma that is metastatic or unresectable. Subjects must have a history of cutaneous, mucosal, or unknown primary site.
  2. Subjects who have received prior systemic cytotoxic chemotherapy for treatment of melanoma are ineligible. The following groups are eligible with regard to prior systemic therapy weither in the adjuvant or metastatic disease setting: a) no prior therapy; b) immunotherapy consisting of interferon, interleukin-2 GM-CSF or vaccine.; and c) One prior investigational therapy (cannot be chemotherapy or an inhibitor of Ras, Raf, or MEK).
  3. Prior radiation therapy is allowed, however, if radiation has been administered to a lesion, there must be radiographic evidence of progression of that lesion in order for that leasion to constitute measurable disease or to be included in the measured target lesions.
  4. All sites of disease must be evaluated within 4 weeks of registration. Subjects must have measurable disease as defined by RECIST.
  5. ECOG Performance status of 0 or 1.
  6. SUbject must not have ocular melanoma.
  7. Subject must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal, or lobular carcinoma in situ of the breast. Subjects with other malignancies are eligible if they have been continuously disease-free for more than 5 years prior to randomization.
  8. Subject must not have evidence of bleeding diathesis.
  9. Subject must not receive any other investigational agents during the period on study or the 4 weeks prior to initiation of treatment.
  10. Other criteria, as determined by the protocol.

For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.

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