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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00970996
First received: September 2, 2009
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Melanoma
Drug: Temozolomide
Drug: Abraxane
Drug: Cisplatin
Biological: Interleukin-2
Biological: Interferon alpha 2b
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Radiographic studies (CT, MRI scans) to assess disease response after every two cycles (one cycle=21 days). ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00970996

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00970996     History of Changes
Other Study ID Numbers: 2009-0124
Study First Received: September 2, 2009
Last Updated: December 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Melanoma
Abraxane
Nab-paclitaxel
Paclitaxel (protein-bound)
ABI-007
Cisplatin
Platinol-AQ
Platinol
CDDP
Interleukin 2
IL-2
Proleukin
Intron A
Interferon alpha 2b
Interferon alfa-2b
Temodar
Temozolomide

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Aldesleukin
Reaferon
Temozolomide
Cisplatin
Interleukin-2
Dacarbazine
Paclitaxel
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014