Status:
COMPLETED
Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Melanoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon alfa-2b, and in...
Detailed Description
The Study Drugs: Cisplatin, nab-paclitaxel, and temozolomide are chemotherapy drugs and have a direct effect on melanoma cells. Interferon alfa-2b and IL-2 are biotherapy drugs that stimulate the imm...
Eligibility Criteria
Inclusion
- Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible.
- They should have recurrent melanoma with measurable or evaluable sites of disease, 1.0 cm or larger, in order to assess the response to treatment by RECIST.
- They should not have been exposed to any previous chemotherapy or isolation perfusion for malignant melanoma and have had no previous exposure to interleukin-2. Prior adjuvant interferon is permitted.Prior radiation therapy for metastatic melanoma is permitted provided the patient has un-irradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
- Patients between 18 years of age and 65 years of age with an expected survival greater than 8 weeks and a Karnofsky performance status of 50% or better or an ECOG performance status of 0, 1 or 2 will be eligible.
- They should have normal blood counts with a WBC 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 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 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.
- They should have no significant intercurrent illness such as an active infection, uncontrolled psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active GI bleeding.
Exclusion
- Patients with bone metastases only.
- Patients with brain metastases unless their disease has been resected and they are off corticosteroids. Patients with spinal cord compression and leptomeningeal disease. No major surgery or radiation therapy within 21 days before starting treatment.
- Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (EF less than 55%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients with an EKG disclosing an absolute QT interval greater than 460 msec in the presence of serum potassium greater than or equal 4.0 mEq/L and magnesium greater than/=1.8 mg/dL.
- Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of FEV1 to less than 75% of predicted normal values.
- Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
- Patients who are unable to stay in Houston to receive therapy (first cycle) and/or 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 5 years and uncertainty about the histological nature of the metastatic lesions.
- Patients with history of DVT or PE are excluded.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00970996
Start Date
September 1 2009
End Date
December 1 2012
Last Update
January 3 2013
Active Locations (1)
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1
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030