Status:
TERMINATED
Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma
Lead Sponsor:
University of Utah
Conditions:
Cancer
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study is a prospective phase II trial of radiation therapy concurrent with cisplatin chemotherapy in the treatment of locally advanced or metastatic melanoma in patients who are deemed to require ...
Detailed Description
This is a phase II, prospective trial designed to determine the response rate achieved with cisplatin delivered concurrent with radiation therapy in locally advanced or metastatic melanoma. Radiation...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Signed study-specific consent form prior to registration.
- Pathologically confirmed malignant melanoma.
- Measurable melanoma lesion deemed to require radiation by treating physicians for purposes of local control or palliation. The lesion may be the primary melanoma, a nodal metastasis, or a distant metastasis. Recurrent lesions are allowed.
- Lesion has to be measurable clinically or radiographically in 2 dimensions.
- Karnofsky Performance Scale (KPS) \> 70.
- Laboratory values
- White blood cells (WBC) \> 3000/mm3
- Absolute granulocyte count \> 1,500
- Platelets \> 100,000/mm3
- Total bilirubin \< 2.0 x institutional upper limit of normal
- AST or ALT (aminotransferase/alanine aminotransferase) \< 2.5 x institutional upper limit of normal
- Serum calcium \< 1.3 x institutional upper limit of normal
- Serum creatinine \< 1.5 mg/dL or Creatinine clearance \> 50 cc/min,calculated as follows: CCr = 0.85 x (140-age) x (weight in kg) 72 x serum creatinine in mg/dL
- Exclusion criteria:
- Systemic therapy for malignant melanoma within one month preceding trial enrollment.
- Prior irradiation to the planned field.
- Concomitant chemotherapy (in addition to cisplatin) or biologic therapy is allowed.
- Significant infection or other co-existent medical condition which would prevent the use of full dose chemotherapy.
- Pre-existing sensory neuropathy (CTC 3.0 ≥ Grade II)
- Pregnancy or lactation.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00707161
Start Date
September 1 2005
End Date
February 1 2010
Last Update
March 31 2017
Active Locations (2)
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1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
2
LDS Hospital
Salt Lake City, Utah, United States, 84143