| Stanford
is an active participant in the Eastern Cooperative
Oncology Group (ECOG) multicenter clinical trials
for melanoma, and a number of ECOG/Intergroup studies
are open for patients with high risk cutaneous disease,
regional nodal metastasis, and disseminated disease.
Stanford ECOG Melanoma Protocols
1.
E1602: A Randomized Phase II Trial of Multi-epitope
Vaccination with Melanoma Peptides for Cytotoxic T-Cells
and Helper T-Cells for Patients with Metastatic Melanoma
Purpose:
To determine the cytotoxic T cell (CTL) response to
each of 12 melanoma peptides in vaccinated patients
with or without helper peptides. To estimate
the rates of clinical response and survival, in patients
vaccinated with a multi-peptide vaccine vaccine consisting
of epitopes for CTL alone, epitopes for T-helper cells
alone, or both.
Open
to metastatic melanoma including mucosal, ocular
and unknown primary. Patients must be HLA
A1, A2, or A3 positive. Select patients with
brain metastasis may be included. Requires two
undissected extremity nodal basins
2.
E2603: A Double-blind, Randomized, Placebo-Controlled
Phase III Trial of Carboplatin, Paclitaxel and Sorafenib
(BAY 43-9006) versus Carboplatin, Paclitaxel and Placebo
in Patients with Unresectable Locally Advanced or
Stage IV Melanoma
Purpose:
This randomized, phase III trial is studying chemotherapeutic
agents (carboplatin and paclitaxel) alone and in combination
with sorafenib (a targeted B-RAF inhibitor), to assess
response in patients with unresectable stage III or
IV melanoma
This
is a trial for newly diagnosed patients or patients
who have never received chemotherapy and includes
mucosal or unknown primary melanoma patients.
Patients with ocular melanoma or brain metastasis
are excluded.
3. E1697: A Phase III Randomized Study of Four
Weeks High-Dose Interferon Alfa-2b in Stage T2-T4
or N1 (Microscopic) Melanoma
For
newly diagnosed Stage IB (> 1.5 mm), Stage IIA-C,
Stage IIIA melanoma
4. E4697: A Randomized Placebo-Controlled Phase
III Trial of Yeast Derived GM-CSF Vs Peptide Vaccination
Vs GM-CSF Plus Peptide Vaccination Vs Placebo in Patients
with ‘No Evidence of Disease’ after Complete Surgical
Resection of ‘Locally Advanced’ and/or Stage IV Melanoma
Patients
must also be HLA-A2 positive. Trial also includes
ocular and mucosal melanoma.
Dr. Steven O'Day, Cancer Institute Medical Group
Clinical Trials at
The Angeles Clinic and Research Institute
1. A Phase II Trial
of AmplimexonTM (imexon,inj.) Plus Dacarbazine (DTIC)
in chemotherapy Naïve Patients with Unresectable
Stage III or Stage IV Malignant Melanoma
2. Randomized, Double-Blind,
Placebo-Controlled Phase II Study Comparing the Safety
of MDX-010 Administered with or Without Prophylactic
Oral Budesonide (Entocort EC) in Patients with Unresectable
Stage III or IV Malignant Melanoma
3. A Multi-Center, Single
Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy
in Patients with Previously Treated Unresectable Stage
III or IV Melanoma
4. A Randomized, Double-Blind,
Multi-Center, Phase II Fixed Dose Study of Multiple
Doses of Ipilimumab (MDX-010) Monotherapy in Patients
with Previously Treated Unresectable Stage III or
IV Melanoma
5. A Multi-Center, Open
Label, Phase II Study of Ipilimumab (MDX-010) Extended-Treatment
Monotherapy or Follow Up for Patients Previously Enrolled
in Ipilimumab (MDX-010) Protocols
6. A Phase II, Multi-Center,
Blinded, Randomized, Controlled Study of the Safety
and Efficacy of the Human Monoclonal Antibody to Humana?
Integrins (CNTO95), alone and in Combination with
Dacarbazine, in Subjects with Stage IV Melanoma
7. A Randomized, Double-Blind,
Multicenter Study Comparing MDX-010 Monotherapy, MDX-010
in Combination with a Melanoma Peptide Vaccine, and
Melanoma Peptide Vaccine Monotherapy in HLA-A*0201-Positive
Patients with Previously Treated Unresectable Stage
III or IV Melanoma REGIMEN (double-blind): MDX-010
alone,MDX-010+Vaccine, Vaccine alone
8. Phase II Multicenter
study of induction Biochemotherapy concurrent Biochemotherapy
followed by Prophylactic Cranial Irradiation/ Temozolomide
and Maintenance Biotherapy in Responding Patients
with Metastatic Melanoma
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