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

May 4, 2008
May 7, 2008
March 20, 2013
April 26, 2013
January 13, 2016
March 2007
January 2009   (Final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: 3 weeks, 6 weeks, 16 weeks, & 24 weeks ]
Terminated study before accrual goal, no data analysis
Progression Free Survival (PFS) [ Time Frame: 3 weeks, 6 weeks, 16 weeks, & 24 weeks ]
Complete list of historical versions of study NCT00673361 on Archive Site
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 ]
Response rate as determined by 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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Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma
Phase II Pilot Trial of "Chemo-Switch" Regimen of Biochemotherapy Followed by Daily Low-Dose Temozolomide Plus Sorafenib in Advanced Melanoma
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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Experimental: "Chemo-Switch" Regimen
  • Drug: Concurrent decrescendo biochemotherapy regimen
  • Drug: Low-dose Temozolomide plus Sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2009
January 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
SR05-888 ( Other Identifier: Legacy Study ID )
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Duke University
Duke University
Principal Investigator: Michael A Morse, M.D. Duke University
Duke University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP