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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00004022
First received: November 1, 1999
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • SWOG 0 or 1

Life expectancy:

  • At least 6 months

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine normal

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • At least 2 weeks since prior therapy and recovered
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004022

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

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00004022     History of Changes
Other Study ID Numbers: CDR0000067241, P30CA022453, WSU-C-1403-ME, NCI-G99-1565
Study First Received: November 1, 1999
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Muromonab-CD3
Aldesleukin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antineoplastic Agents
Therapeutic Uses
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 29, 2014