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Клинические исследования в Украине

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Исследования / № 00039000

Описание
Краткое названиеStudy of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma
Полное названиеA Phase III Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus Physician's Choice Including Interleukin-2 and/or Dacarbazine/Temozolomide-Based Therapy and/or Complete Tumor Resection in Stage IV Melanoma
СпонсорAntigenics
Industry
ИсточникAntigenics
Под контролемUnited States: Food and Drug Administration
Краткое описаниеThe primary goal of this study is to determine if people with metastatic melanoma who
receive Heat Shock Protein-Peptide Complex - 96 (HSPPC-96 or Oncophage) after surgery live
longer than people who may or may not have surgery but who receive conventional chemotherapy
including IL-2/DTIC. A second goal is to determine the safety and frequency of side effects
in subjects who receive therapy with HSPPC-96.
СостояниеЗавершено
Дата началаMarch 2002
ФазаPhase 3
Подробное описаниеPrimary Objective:

- To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer
survival than subjects randomized to physician's choice including interleukin-2 and/or
dacarbazine/temozolomide and/or complete tumor resection.

Secondary Objective:

- To determine frequency of adverse events in subjects randomized to HSPPC-96.
Вид исследованияAllocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор350
КритерииEligibility Assessment:

(The following assessments must be obtained within three weeks prior to randomization into
the study)

- Medical history and physical examination (including EGOG score, evidence of
immunosuppression);

- CT/MRI of the chest, abdomen and pelvis;

- Clinical examination;

- CT/MRI of the brain;

- Complete Blood Count with differential including platelets;

- Electrolytes (Na, Cl, K, HCO3, Ca, Mg, PO4);

- Renal function tests (BUN and creatinine);

- Liver function tests (bilirubin, AST, ALT);

- Serum pregnancy test for all women of childbearing potential.

Inclusion Criteria:

- Stage IV Melanoma (AJCC);

- No prior therapy for stage IV melanoma;

- No prior therapy with interleukin-2 and/or dacarbazine/temozolomide within the past
12 months prior to study entry;

- Candidate for surgical resection of some/all sites of melanoma and expected to obtain
greater tan or equal to 7 grams of viable cancer tissue (in aggregate), which is
equivalent to a greater than or equal to 2 cm lesion on CT/MRI or clinical
examination;

- No brain metastases;

- ECOG score 0 or 1;

- Adequate cardiac function;

- Adequate hematopoietic, liver and renal function;

- Female subjects of child-bearing potential must agree to use contraception during the
study

- Signed written informed consent.

Exclusion Criteria:

- Mucosal or ocular melanomas;

- Other malignancies treated within the last five years, except in situ cervix
carcinoma or non-melanoma skin cancer;

- Primary or secondary immunodeficiency, in the opinion of the investigator (including
immunosuppressive disease, or use of systemic corticosteroids or other
immunosuppressive medications);

- Prior splenectomy;

- Uncontrolled infection or other serious medical illnesses;

- Women who are pregnant or breast-feeding;

- Subjects participating in any other studies requiring administration of an
investigational drug/biologic agent.
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеMalignant Melanoma
Применяемое лечение
DrugHSPPC-96 or Oncophage
Контакты и расположение
Dnepropetrovsk
Donetsk
Ivano-Frankovsk
Kiev
Krivoy Rog
Lviv
Odessa
Uzhgorod
Vinnitsa
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