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Phase II Pilot Trial of "Chemo-Switch" Regimen of Biochemotherapy Followed by Daily Low-Dose Temozolomide Plus Sorafenib in Advanced Melanoma

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

Phase II Pilot Trial of "Chemo-Switch" Regimen of Biochemotherapy Followed by Daily Low-Dose Temozolomide Plus Sorafenib in Advanced Melanoma

Inclusion Criteria:

- Must have histologically or cytologically confirmed melanoma that is locally advanced
or metastatic. Cutaneous, mucosal, ocular, and unknown primary melanoma are all

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

Terminated study before accrual goal, no data analysis

Outcome Time Frame:

3 weeks, 6 weeks, 16 weeks, & 24 weeks

Safety Issue:


Principal Investigator

Michael A Morse, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:

9361 (SR05-888)



Start Date:

March 2007

Completion Date:

January 2009

Related Keywords:

  • Melanoma
  • Melanoma