Cancer, Melanoma
Conditions
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 radiation therapy by treating physicians for purposes of local control or palliation. Eligibility criteria include pathologically confirmed melanoma. Patients will undergo radiation therapy (20 treatments of 2.5 Gy for a total of 50 Gy) concurrent with cisplatin chemotherapy.
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 therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments). Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation. Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians). If the patient's tumor has inadequate response to chemoradiation then salvage therapies can be used as deemed appropriate by the treating physicians. In order to allow adequate response to radiation therapy, salvage therapies will not be utilized until at least 4 weeks following chemoradiation unless deemed emergent by the treating physicians.
Interventions
RADIATIONRadiation Therapy
Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments).
DRUGCisplatin
Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
PROCEDURESurgical resection
Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate of Melanoma Lesions | 2005-2010 | Response rate of melanoma lesions was measured after treated with the trial agent. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm (Radiation Therapy & Cisplatin) Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 6 |
Baseline characteristics
| Characteristic | Treatment Arm (Radiation Therapy & Cisplatin) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 67.6 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Response Rate of Melanoma Lesions
Response rate of melanoma lesions was measured after treated with the trial agent.
Time frame: 2005-2010
Population: Study terminated. Analysis not conducted.