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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

C-100-21

NCT ID:

NCT00039000

Start Date:

March 2002

Completion Date:

December 2005

Related Keywords:

  • Malignant Melanoma
  • Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor
  • Melanoma

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Louisville, Kentucky  40207
Kansas City, Kansas  66160
Hackensack, New Jersey  07601
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Eugene, Oregon  
Milwaukee, Wisconsin  
Lebanon, New Hampshire  
Tulsa, Oklahoma