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

NCT00970996 | Completed Phase 1

• 1 other identifier: 2009-0124
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Radiographic studies (CT, MRI scans) to assess disease response after every two cycles (one cycle=21 days).

Study Arms (1)

Biochemotherapy

EXPERIMENTAL

Abraxane with Cisplatin, Temozolomide, interleukin-2 and interferon a2b

Drug: Temozolomide; Drug: Abraxane; Drug: Cisplatin; Biological: Interleukin-2; Biological: Interferon alpha 2b

Interventions

Temozolomide DRUG

250 mg/m\^2 by mouth on days 1, 2, and 3 of each 21-day cycle.

Also known as: Temodar

Biochemotherapy

Abraxane DRUG

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.

Also known as: Nab-paclitaxel, Paclitaxel (protein-bound), ABI-007

Biochemotherapy

Cisplatin DRUG

20 mg/m\^2 intravenously on days 1, 2, 3, and 4 delivered immediately after Abraxane of each 21-day cycle.

Also known as: Platinol-AQ, Platinol, CDDP

Biochemotherapy

Interleukin-2 BIOLOGICAL

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.

Also known as: IL-2, Proleukin

Biochemotherapy

Interferon alpha 2b BIOLOGICAL

5 MIU/m\^2 in subcutaneous injection on days 1, 2, 3, 4, and 5 of each 21-day cycle.

Also known as: Intron A

Biochemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• U.T. M.D. Anderson Cancer Center web page

MeSH Terms

Conditions

Melanoma

Interventions

Temozolomide; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Taxes; Cisplatin; Interleukin-2; aldesleukin; Interferon alpha-2; Introns

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Lymphokines; Biological Factors; Interferon-alpha; Interferon Type I; Interferons; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Nicholas E. Papadopoulos, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 3, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

US (1)