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Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma (BCAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00970996
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : January 3, 2013
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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 interleukin-2 (IL-2) to patients with metastatic melanoma.

Primary Objective:

  • The primary objective of the Phase I is to determine the toxicity, safety and the maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin, Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma.

Secondary Objectives:

  • To assess responses to the combination.
  • To evaluate the duration of response and the overall survival.
  • To determine the effectiveness in delaying the appearance of Central Nervous System disease.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Temozolomide Drug: Abraxane Drug: Cisplatin Biological: Interleukin-2 Biological: Interferon alpha 2b Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Biochemotherapy With Cisplatin, Temozolomide, With Increasing Doses of Abraxane, Combined With Interleukin-2 and Interferon in Patients With Metastatic Melanoma
Study Start Date : September 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Biochemotherapy
Abraxane with Cisplatin, Temozolomide, interleukin-2 and interferon a2b
Drug: Temozolomide
250 mg/m^2 by mouth on days 1, 2, and 3 of each 21-day cycle.
Other Name: Temodar

Drug: Abraxane
100 mg/m^2 given in a short intravenous infusion 1 hour after completion of Temozolomide and a 2nd dose of 70 mg/m^2 given on day 5 of each 21-day cycle.
Other Names:
  • Nab-paclitaxel
  • Paclitaxel (protein-bound)
  • ABI-007

Drug: Cisplatin
20 mg/m^2 intravenously on days 1, 2, 3, and 4 delivered immediately after Abraxane of each 21-day cycle.
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP

Biological: Interleukin-2
9 MIU/m^2 in a continuous intravenous infusion over 24 hours on days 1, 2, 3, and 4 (total of 96 hours) beginning after completion of Cisplatin of each 21-day cycle.
Other Names:
  • IL-2
  • Proleukin

Biological: Interferon alpha 2b
5 MIU/m^2 in subcutaneous injection on days 1, 2, 3, 4, and 5 of each 21-day cycle.
Other Name: Intron A

Primary Outcome Measures :
  1. Response Rate [ Time Frame: Radiographic studies (CT, MRI scans) to assess disease response after every two cycles (one cycle=21 days). ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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 Criteria:

  1. Patients with bone metastases only.
  2. 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.
  3. 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.
  4. 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.
  5. Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
  6. 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.
  7. 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.
  8. Patients with history of DVT or PE are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00970996

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United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Nicholas E. Papadopoulos, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00970996    
Other Study ID Numbers: 2009-0124
First Posted: September 3, 2009    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: December 2012
Keywords provided by M.D. Anderson Cancer Center:
Paclitaxel (protein-bound)
Interleukin 2
Intron A
Interferon alpha 2b
Interferon alfa-2b
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon alpha-2
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic