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Biological Therapy Following Surgery in Treating Patients With Stage III or Stage IV Melanoma

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 13, 2004
Last Update Posted: April 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery in treating patients who have stage III or stage IV melanoma.

Condition Intervention Phase
Melanoma (Skin) Biological: aldesleukin Biological: autologous tumor cell vaccine Biological: muromonab-CD3 Biological: therapeutic autologous lymphocytes Procedure: surgical procedure Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Immunotherapy for Malignant Melanoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy

Resource links provided by NLM:

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Study Start Date: June 1997
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Detailed Description:


  • Evaluate the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and sargramostim (GM-CSF) followed by monoclonal antibody OKT3- activated T lymphocytes and interleukin-2 in combination with surgery in terms of response rate in patients with stage III or IV malignant melanoma.
  • Determine the immunogenicity of malignant melanoma in this patient population.

OUTLINE: Patients are stratified according to extent of disease, extent of antigen specific response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender.

Patients undergo surgical resection of tumor on week 1. Within 1-2 weeks of surgery, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF), then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 2 weeks later.

Patients undergo peripheral blood mononuclear cell collection two weeks after the second vaccination. Peripheral blood mononuclear cells are stimulated with anti-CD3 monoclonal antibody (OKT3) and interleukin-2, producing activated T lymphocytes. The activated T lymphocytes are infused IV over 1-6 hours followed by 5 doses of interleukin-2 IV every other day over 10 days. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients may receive one additional course of immunotherapy as above.

Patients are followed every 3 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven stage III or IV malignant melanoma
  • Resectable disease
  • At least 50,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study



  • 18 and over

Performance status:

  • SWOG 0 or 1

Life expectancy:

  • At least 6 months


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least lower limit of normal
  • No active or recent uncontrolled bleeding


  • Bilirubin normal
  • SGOT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)


  • Creatinine normal


  • Negative stool guaiac
  • No impaired immunity
  • No uncontrolled diabetes
  • No active uncontrolled infections
  • No other serious disease
  • No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • Not specified


  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics


  • At least 2 weeks since prior therapy and recovered
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004022

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Roy D. Baynes, MD, PhD, FACP Barbara Ann Karmanos Cancer Institute
  More Information

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00004022     History of Changes
Other Study ID Numbers: CDR0000067241
P30CA022453 ( U.S. NIH Grant/Contract )
First Submitted: November 1, 1999
First Posted: September 13, 2004
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents