Status:
TERMINATED
Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma
Lead Sponsor:
Duke University
Collaborating Sponsors:
Bayer
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00673361
Start Date
March 1 2007
End Date
January 1 2009
Last Update
January 13 2016
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