| Clinical
Trial: |
S0008
- High Risk Melanoma |
| Governing Group: |
Southwest Oncology
Group |
| Title: |
"A Phase III
Trial of High Dose Interferon Apha-2b Versus Cisplatin, Vinblastine,
DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma." |
Eligibility:
-
Only patients with melanoma of cutaneous origin or of unknown
primary are eligible for this study.
-
Patients with unknown primary are not eligible if visceral disease
is present. All other patients with distant metastases are not
eligible.
-
Patients with melanoma of ocular, mucosal or other non-cutaneous
origin are not eligible.
-
All patients with newly diagnosed or recurrent disease must fulfill
at least one of the eligibility criteria a in section 5.1 of the
protocol as well as meet the staging criteria as outlined in section
4.0.
-
Patients are eligible for this trial at initial presentation of
their melanoma or at the time of the first detected nodal, satellite/in-transit
or recurrent disease in prior lymphadenectomy basin.
-
Nodal, satellite/in-transit metastasis or recurrent disease in
prior complete lymphadenectomy basin must have been confirmed
histologically by H & E stained slides.
-
Patients with multiple regional nodal basin involvement are permitted
as long as they are the appropriate anatomic drainage basins for
the primary site.
-
Gross or microscopic extracapsular nodal extension is permitted.
-
No prior radiation, chemo (including infusion or perfusion therapy),
or any immunotherapy with IFN and/or interleukins for any type
of cancer (except post-lumpectomy radiation for breast cancer).
-
Patients must have adequate hepatic, renal and hematologic.
-
Patients must not have evidence of symptomatic congestive heart
failure, symptoms of coronary arty disease or serious cardiac
conditions.
-
Performance status of 0-1.
-
Not planning to receive other biologic therapy, radiation therapy,
hormonal therapy, other chemotherapy, surgery, or other therapy
while on this protocol.
|
