Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma

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: NCT00673361
Recruitment Status : Terminated
First Posted : May 7, 2008
Results First Posted : April 26, 2013
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):
Duke University

Brief Summary:
This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Concurrent decrescendo biochemotherapy regimen Drug: Low-dose Temozolomide plus Sorafenib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Pilot Trial of "Chemo-Switch" Regimen of Biochemotherapy Followed by Daily Low-Dose Temozolomide Plus Sorafenib in Advanced Melanoma
Study Start Date : March 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: "Chemo-Switch" Regimen Drug: Concurrent decrescendo biochemotherapy regimen
  • Temozolomide: 200mg/m^2, daily, PO, days 1-4
  • Vinblastine: 1.5mg/m^2, daily, IV, days 1-4
  • Cisplatin: 20mg/m^2, daily IV, days 1-4
  • IL (interleukin)-2: - 18 milli-International unit (MIU)/m^2, IVCI (intravenous continual infusion), day 1
  • 9 MIU/m^2, IVCI, day 2
  • 4.5 MIU/m^2, IVCI, days 3 & 4
  • Interferon (IFN) alpha: 5 MIU/m^2, daily, SC (subcutaneously), days 1-5
  • 5-day inpatient regimen, to be repeated every 21 days

Drug: Low-dose Temozolomide plus Sorafenib
Temozolomide: 75mg/m^2, PO, QD (quaque die), 6 weeks on/2 weeks off Sorafenib: 400mg, PO, BID, 8 weeks

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 3 weeks, 6 weeks, 16 weeks, & 24 weeks ]
    Terminated study before accrual goal, no data analysis

Secondary Outcome Measures :
  1. Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [ Time Frame: post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years ]

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

Inclusion Criteria:

  • Must have histologically or cytologically confirmed melanoma that is locally advanced or metastatic. Cutaneous, mucosal, ocular, and unknown primary melanoma are all eligible.
  • Must have measurable disease, defined by RECIST as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20mm with conventional techniques or >10mm with spiral CT scan.
  • May have received prior radiation therapy to one or more non-index lesions (prior radiation to an index lesion is allowable only if progression of the irradiated lesion is demonstrated, with progression defined as an increase of 20% or more in the largest diameter) and/or one prior vaccine therapy for metastatic disease. Prior adjuvant therapy with IFN alpha-2b, vaccine, and/or granulocyte-macrophage colony-stimulating factor (GM-CSF) is permitted. At least 4 weks must have elapsed since the completion of any prior therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes >3,000/uL (microliters)
  • absolute neutrophil count >1,500/uL
  • platelets >100,000/uL
  • total bilirubin <2.0mg/dL
  • AST (Aspartate transaminase)(SGOT)/ALT (Alanine transaminase)(SGPT) <2.5 X institutional upper limit of normal
  • creatinine <1.8mg/dL
  • If >50 years of age with one or more cardiac risk factors, must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation.
  • Must be at least 2 weeks out from major surgery and be free of any active infection requiring antibiotics.
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Women must demonstrate a negative pregnancy test prior to initiation of protocol therapy.
  • Ability to understand and the willingness to sign a written informed consent form.

Exclusion Criteria:

  • Prior chemotherapy, cytokine therapy (including IL-2 or IFN alpha), or antibody therapy for metastatic disease. Prior vaccine therapy is permitted.
  • May not be currently receiving any other antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccine, or investigational agents.
  • History of brain metastases.
  • Autoimmune disorders that could result in life-threatening complications in the setting of IFN alpha and IL-2 treatment.
  • History of sensitivity to E. coli-derived products.
  • Concurrent use of corticosteroids or any medical condition likely to require the use of systemic corticosteroids.
  • A seizure disorder currently requiring anti-epileptic medication.
  • Uncontrolled intercurrent illness including, but not limited to, hypertension, active infection requiring antibiotic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Evidence of bleeding diathesis.
  • Currently on therapeutic anticoagulation. Prophylactic anticoagulation (such as low-dose warfarin) of venous or arterial access devices is allowed provided the PT, PTT (Partial Thromboplastin Time), and international normalized ratio (INR) are normal.

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): NCT00673361

Sponsors and Collaborators
Duke University
Principal Investigator: Michael A Morse, M.D. Duke University

Responsible Party: Duke University Identifier: NCT00673361     History of Changes
Other Study ID Numbers: 9361
SR05-888 ( Other Identifier: Legacy Study ID )
First Posted: May 7, 2008    Key Record Dates
Results First Posted: April 26, 2013
Last Update Posted: January 13, 2016
Last Verified: December 2012

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents