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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00039000
Other study ID # C-100-21
Secondary ID
Status Completed
Phase Phase 3
First received June 6, 2002
Last updated September 6, 2012
Start date March 2002
Est. completion date December 2005

Study information

Verified date September 2012
Source Agenus, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The 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.


Description:

Primary 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.


Other known NCT identifiers
  • NCT00047359

Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
HSPPC-96 or Oncophage


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Agenus, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Hungary,  Italy,  Poland,  Russian Federation,  Sweden,  Ukraine,  United Kingdom, 

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