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

Tracking Information
First Submitted Date ICMJE	May 4, 2008
First Posted Date ICMJE	May 7, 2008
Results First Submitted Date	March 20, 2013
Results First Posted Date	April 26, 2013
Last Update Posted Date	January 13, 2016
Study Start Date ICMJE	March 2007
Actual Primary Completion Date	January 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 20, 2013)	Progression Free Survival (PFS) [ Time Frame: 3 weeks, 6 weeks, 16 weeks, & 24 weeks ]; Terminated study before accrual goal, no data analysis
Original Primary Outcome Measures ICMJE; (submitted: May 4, 2008)	Progression Free Survival (PFS) [ Time Frame: 3 weeks, 6 weeks, 16 weeks, & 24 weeks ]
Change History	Complete list of historical versions of study NCT00673361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 20, 2013)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: May 4, 2008)	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 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma
Official Title ICMJE	Phase II Pilot Trial of "Chemo-Switch" Regimen of Biochemotherapy Followed by Daily Low-Dose Temozolomide Plus Sorafenib in Advanced Melanoma
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Melanoma
Intervention ICMJE	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
Study Arms	Experimental: "Chemo-Switch" Regimen; Interventions: Drug: Concurrent decrescendo biochemotherapy regimen; Drug: Low-dose Temozolomide plus Sorafenib
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: March 20, 2013)	9
Original Estimated Enrollment ICMJE; (submitted: May 4, 2008)	40
Actual Study Completion Date	January 2009
Actual Primary Completion Date	January 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	United States
Administrative Information
NCT Number ICMJE	NCT00673361
Other Study ID Numbers ICMJE	9361; SR05-888 ( Other Identifier: Legacy Study ID )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Duke University
Study Sponsor ICMJE	Duke University
Collaborators ICMJE	Bayer
Investigators ICMJE	Principal Investigator: Michael A Morse, M.D. Duke University
PRS Account	Duke University
Verification Date	December 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP