Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma

A 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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00039000

Enrollment

350

Registered

2002-06-10

Start date

2002-03-31

Completion date

2005-12-31

Last updated

2012-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Keywords

Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor

Brief 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.

Detailed 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.

Interventions

DRUGHSPPC-96 or Oncophage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Countries

Australia, Hungary, Italy, Poland, Russia, Sweden, Ukraine, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026